Careers

Excellent opportunities have arisen to work in one of the most exciting areas of modern medicine within this innovative pharmaceutical company. 

 

GW Pharmaceuticals was founded in 1998 and is listed on both the NASDAQ Global Market (GWPH) and AIM, a market of the London Stock Exchange,. GW is licensed by the UK Home Office to work with a range of controlled drugs for medical research purposes. The Group's lead programme is the development of a product portfolio  of cannabinoid prescription medicines to meet patient needs in a wide range of therapeutic indications, including Sativex® Oromucosal Spray and Epidiolex® for childhood epilepsy.

 

GW has assembled a large in-house team with extensive experience in developing cannabinoids, medicines containing controlled substances, as well as plant-based prescription pharmaceutical products. GW maintains in-house control over all aspects of the cannabinoid product development process. GW also holds GMP manufacturing licences for the manufacture of pharmaceutical products for both clinical trials and commercial purposes

 

For details of GW’s current marketed product and international clinical research programme please refer to information on the company’s website: www.gwpharm.com .

 

To apply for an advertised position please send your CV together with a covering letter stating your salary expectations to recruitment@gwpharm.com.

 

Unfortunately we are currently unable to consider any speculative applications and so please do not apply for a position unless you believe yourself to be well suited to those advertised.

 

For all other recruitment enquiries please e-mail recruitment@gwpharm.com.

 

Quality Assurance Executive - Horticulture

 

Permanent

 

The Role

  • To assist in the implementation of the Quality System
  • To work with all necessary departments to ensure the GMP and the GACP system is current and in compliance with the current guidelines and company filings.
  • To review and work to continuously improve compliance
  • To assist in the development QA staff members, training and mentoring as required

Key Responsibilities

  • Develop the quality management framework
  • Reviewing of batch records or, validation documentation
  • Leading and assisting in departmental investigations
  • Day to day training, mentoring and supporting of more junior members of the department.
  • Support the regular review and development of the Quality Systems within the area of specialism.
  • Monitoring and continuously improving quality metrics.
  • Assist or lead audits (external and internal) as required
  • Monitoring and auditing of contract manufacturing organisations (CMO’s)

Essential Skills

  • Experience working in an EU regulated pharmaceutical manufacturing site in a quality role is essential. Experience in an IMP or API regulated environment would be beneficial.
  • Experience of working in horticulture with a quality systems focus or a quality assurance background with some interest in horticulture would be advantageous.
  • Experience in working within a contract manufacturing environment.
  • Demonstrable experience of working with a variety of quality management systems including change control, technical investigations (complaints, OOS, deviations, failure investigations, etc) and auditing (external and internal).
  • Experience of developing and sustaining QMS systems would be beneficial.
  • Experience of preparing for regulatory audits or presenting to MHRA, FDA.
  • Experience in using root cause analysis or problem solving tools including statistical process controls.
  • Experience in running or assisting in quality risk assessment

 

Location: South East 

 

To apply please send your CV with salary expectations to recruitment@gwpharm.com

Quality Assurance Executive IMP

 

Permanent

 

The Role

  • To assist the Quality Assurance Manager and other QA team members in implementation of the Quality System.
  • To work with all necessary departments to ensure the GMP and the GACP system is current and in compliance with the current guidelines and company filings.
  • To review and work to continuously improve compliance through promoting QA and developing sustainable quality systems as directed by Senior Quality Assurance Executives (SQAE) and quality management team.
  • To assist in the development QA staff members, training and mentoring as required.

 

Key Responsibilities

  • The job holder is responsible for maintaining cGxP and EHS knowledge applicable to the job.
  • Reviewing of batch records or, validation documentation.
  • Leading and assisting in departmental investigations including Deviations, OOS, OOE, OOT and complaints.
  • Day to day training, mentoring and supporting of more junior members of the department.
  • Support the regular review and development of the Quality Systems within the area of specialism as required by ICH Q10.
  • Monitoring and continuously improving quality metrics (KPI) pertinent to area of specialism.
  • Assist or lead audits (external and internal) as required supporting the KSP audit programme.
  • Monitoring and auditing of Contract manufacturing organisations (CMO’s) working with GW site quality management.

 

Essential Skills

Knowledge:

  • Education to degree standard, in a scientific or quality systems discipline or experience from vocational training.

 

Experience:

  • Experience of working in an EU regulated pharmaceutical manufacturing site in a quality role is essential. Experience in an IMP or API regulated environment would be beneficial.
  • Demonstrable experience of working with a variety of quality management systems including PQR, change control, technical investigations (complaints, OOS, deviations, failure investigations, etc) and auditing (external and internal).
  • Experience of developing and sustaining QMS systems would be beneficial.
  • Experience of preparing for regulatory audits or presenting to MHRA, FDA.
  • Experience in using root cause analysis or problem solving tools including statistical process controls.
  • Experience in running or assisting in quality risk assessment.

 

Location: South East 

 

To apply please send your CV with salary expectations to recruitment@gwpharm.com

 

Medical Director

 

Permanent

 

The Role

This individual will be responsible for ensuring the global medical integrity of the cannabinoid development program, and shaping and developing the global medical affairs strategy to support one or more GW products that are currently in clinical development and which GW intends to market in the US and ROW. 

 

As such the role can perhaps be best thought of as a ‘hybrid’ one working across R&D and Medical Affairs from both an operational and geographical perspective, with the focus evolving over time.

 

Key Responsibilities

Developing constructive working relationships with external stakeholders including key opinion leaders, principal investigators, patient advocacy groups, and may include regulatory interactions. Internally, key working relationships will be global marketing, US medical affairs, clinical research, and regulatory affairs

 

Essential skills:

  • Broad skill set in Medical Affairs, clinical development, Drug safety and regulatory affairs
  • Strong customer orientation, science based and marketing minded, negotiation skills
  • Operational excellence, Management skills, planning, prioritization, decision making, objective setting, meeting management and plan execution
  • Medical Education (MD);  clinical development and medical affairs.
  • Experience within pharmaceutical or biotech,
  • Knowledge of Pharmaceutical product development, product lifecycle and commercialisation process with advanced understanding of other functions including Clinical Operations, Commercial, regulatory, safety,  medical and market access.
  • Statistical analysis
  • Solid understanding of research study design and relevant development guidelines
  • Medical affairs experience across one or more EU country
  • Neurology specialist experience
  • Strong business acume

 

Desirable skills:

  • Epilepsy experience
  • ABPI code of practice certified
  • Pharmaceutical affiliate and global experience
  • Knowledge of pharmaceutical regulations and pharmacoeconomics
  • Working in cross-functional teams in a matrix environment
  • Finance/budgeting and resource management experience
  • Leadership experience

 

Location: Cambridge

 

To apply please send your CV with salary expectations to recruitment@gwpharm.com

Toxicology Project Manager

 

Permanent

 

The Role

We are seeking an experienced, motivated and talented individual, working within our preclinical team. The role will primarily entail the design, management and reporting of toxicology and safety pharmacology studies to GLP regulations and company SOPs’.

 

Key Responsibilities

  • Design, set up, conduct, tracking and reporting of toxicology and safety pharmacology studies.
  • Preclinical study design and protocol development.
  • Evaluation and selection of CROs, placement and management of studies.
  • Monitor conduct of studies, and participate in the interpretation of study results and finalisation of the final study report.
  • Manage appropriate bioanalytical methodologies and long term stability studies  to support the preclinical programme
  • Ensure good laboratory practice (GLP) compliance in accordance with GW departmental SOPs applicable to such studies.
  • Ensuring non-regulated preclinical studies are run in accordance with the appropriate GW SOPs and relevant regulatory guidelines and legislation.
  • Participate in GW Product Development Plans.
  • Prepare relevant technical sections of documents for regulatory submissions, including Investigational New Drug (IND) applications, Common Technical Documents (CTDs) and Investigator Brochures.

 

The successful candidate will have the following skills and attributes:

  • A degree (BSc, MSc or PhD) in Toxicology or another appropriate scientific discipline.
  • Good toxicology project management skills gained in the pharmaceutical industry or contract research organisation (CRO) environment
  • Knowledge of safety pharmacology and abuse liability studies would be an advantage.
  • Experience in drafting submissions to FDA would be an advantage.
  • General knowledge of the pharmaceutical drug development process desirable.
  • Knowledge of regulatory guidelines and legislation.
  • Experienced in scientific writing
  • Ability to lead, direct, manage, motivate and develop individuals and third parties.
  • Good report writing and presentation skills

Location: Cambridge

 

To apply please send your CV with salary expectations to recruitment@gwpharm.com

Clinical Compliance Officer

 

 12 Month FTC

  

The Role

To promote GCP compliance and process improvements across Clinical Operations and associated functions through both implementation of Corrective and Preventive Actions (CAPAs) for findings arising from audits/inspections, and Standard Operating Procedure (SOP) updates.

 

Key Responsibilities

  • Drive the process of responding to findings and developing CAPAs for investigator site, systems and process audits, and inspections by external agencies (e.g. MHRA, FDA and partners), across Clinical Operations
  • Chair/key contributor to working parties focussed on specific areas of CAPA resolution (e.g. trial start up)
  • Responsible/Accountable to the GCP Compliance Steering Committee for CAPA resolution targets
  • Chair/facilitate Clinical Process Improvement Team, which aims to address issues, identified within CPM/CRA/Clinical Coordination teams, which require cross-functional action/decisions – e.g. CPM action log items, process improvement initiatives.
  • Ensures appropriate tracking of process improvement initiatives.
  • Promote and drive continual process improvement, in line with best practice and regulations
  • Initiate, consult on, implement and provide training (in association with Training & Development Manager and relevant departmental managers) on agreed process improvement initiatives
  • Support departmental inspection readiness activities
  • Draft Standard Operating Procedures (SOPs) and SOP updates, and contribute to SOP globalisation
  • The job holder is responsible for maintaining GCP and H&S knowledge applicable to the job.

 

Essential Skills

  • Substantial experience working in the Pharmaceutical industry in a Clinical Monitoring, Project Management, Quality Assurance or similar role
  • Educated to A-level or above
  • Detailed working knowledge of GCP and current regulations governing clinical trial conduct
  • Attention to detail and methodical approach; strong track-record of ensuring full completion/implementation of activities
  • Computer literate in Microsoft packages
  • Strong communication skills (written and oral)
  • Ability to influence/motivate colleagues, and to promote effective team working
  • Flexible and adaptable to a fast-changing environment
  • Responsible and reliable
  • Excellent time management and organisational skills

Desirable Skills

  • Degree in Biological Science/Nursing Qualification or equivalent
  • Experience on global clinical trials
  • Experience of MHRA/FDA inspections

Location: Cambridge

 

To apply please send your CV with salary expectations to recruitment@gwpharm.com.

By close of play 19th December 2014.

Global Head of Regulatory Affairs

 

Permanent

 

The Role

Direction and management of regulatory aspects of our products, information and activities globally.

 

Key Responsibilities

  • Participating in Strategic Management meetings to formulate regulatory strategy and to provide guidance for the data necessary for global development and marketing authorisation activities.
  • Liaising with Health Authorities and leading Health Authority interactions as required.
  • Development of the Regulatory team.
  • Directing the compilation of Marketing Authorisation Applications (MAA)s and New Drug Applications (NDA)s in liaison with GW staff, Commercial partners and external consultants.
  • Directing the preparation of Clinical Trial Applications (CTA)s and Investigational New Drug (IND) submissions.
  • The job holder is responsible for the overall health, safety, security and environmental protection in their departments.

 

Essential Skills

Knowledge:

  • Life Sciences degree.

 

Experience:

  • Extensive experience in Regulatory Affairs.
  • Regulatory experience to include Europe and USA.
  • Senior Management Team and Line Management experience

 

Location: London

 

To apply please send your CV with salary expectations to recruitment@gwpharm.com

By close of Business 18th December 2014.

 

Director of Regulatory Affairs (Cambridge-Clinical)

 

Permanent

 

The Role

The job holder manages regulatory aspects of our products, information and activities worldwide, with particular emphasis on clinical and nonclinical activities.

 

Key Responsibilities

  • Developing the regulatory strategy for all of GW’s development projects and to advise on any risks and mitigation of those risks, to development timelines.
  • Participating in key meetings as necessary in relation to the regulatory strategy and to provide guidance for the data necessary for Marketing Authorisation Applications (MAAs), Clinical Trial Authorisations (CTAs), Investigational New Drug (IND) dossiers and New Drug Applications (NDAs).
  • Liaising with Health Authorities and leading Health Authority interactions as required.
  • Development of the Regulatory team in Cambridge.
  • Overseeing all clinical submissions to Health Authorities.
  • Liaising with the Pharmacovigilance team in ensuring safety-related documentation is maintained.
  • Maintaining cGxP and H&S knowledge applicable to the job. 

Essential Skills

Knowledge:

  • Life Sciences degree.

 

Experience:

  • Extensive experience in Regulatory Affairs.
  • Regulatory experience to include Europe and USA.
  • Senior Management Experience

Skills:

  • Proven organisational skills, particularly when time constrained.
  • Creative yet attention to detail and regulatory guidance.

 

Location: Cambridge

 

To apply please send your CV with salary expectations to recruitment@gwpharm.com

By close of business 21st December 2014.

Senior Pharmaceutical Development Scientist

 

Permanent

 

The Role

Manage and progress pharmaceutical development projects.

 

Key Responsibilities

  • Manage key projects (Literature searches, Preformulation studies, Formulation development of product, Preparation of prototypes, Manufacture clinical trial materials, Preparation of stability studies, Characterisation of products, Specification development, Compilation of information for regulatory submissions, Scale up to commercial manufacture).
  • Coordinate key aspects of the Pharmaceutical Development department i.e. equipment maintenance, stability studies, write and maintain GMP document for example product specification and SOPs.
  • Responsible for maintaining cGxP, Regulatory Guidelines and H&S knowledge applicable to the job.

 

Essential Skills

 

Knowledge:

  • Degree in Scientific discipline
  • Preferably higher level qualification (PhD)
  • Knowledge of pharmaceutical development within the pharmaceutical industry

Experience:

  • Able to manage a team to ensure smooth running of projects within the department.

Skills:

  • Working knowledge of Microsoft Word and Excel
  • High level of numeracy
  • Communication skills including written and presentational
  • Excellent attention to detail

Attributes and Behaviours:

  • Develops and maintains positive working relationships with others
  • Shares ideas and information
  • Assists colleagues as and when required
  • Demonstrates a ‘can do’ approach

 

Desirable Skills

  • Project management experience

 

Location: South East

 

To apply please send your CV and a cover letter with your salary expectations to recruitment@gwpharm.com  by close of business 19thDecember 2014.

 

Pharmaceutical Development Team Leader

 

Permanent, FTE

 

The Role

The job holder will manage and progress pharmaceutical development projects and deputise for the Pharmaceutical Development Manager as required.

 

Key Responsibilities

  • Manage key projects (Literature searches, pre-formulation studies, formulation development of product, preparation of prototypes, manufacture of clinical trial materials, preparation of stability studies, characterisation of products, specification development, compilation of information for regulatory submissions, scale up to commercial manufacture).
  • Coordinate key aspects of the Pharmaceutical Development department i.e. equipment maintenance, stability studies, write and maintain GMP document for example product specification and SOPs.
  • Responsible for maintaining cGXP and H&S knowledge applicable to the job.
  • Responsible for training and development of direct reporting staff.
  • Responsible for maintaining cGxP, Regulatory Guidelines and H&S knowledge applicable to projects being managed.

 

Essential Skills

 

Knowledge:

  • Degree in Scientific discipline
  • Preferably higher level qualification (PhD)
  • Knowledge of pharmaceutical development within the pharmaceutical industry

 

Experience:

  • A track record of product development in the pharmaceutical industry
  • Knowledge and experience of CMC Regulatory documentation for R&D projects.
  • Project management
  • Team management 

Skills:

  • Working knowledge of Microsoft Word and Excel
  • High level of numeracy
  • Communication skills including written and presentational
  • Excellent attention to detail

Attributes and Behaviours:

  • Develops and maintains positive working relationships with others
  • Shares ideas and information
  • Assists colleagues as and when required
  • Demonstrates a ‘can do’ approach 

Desirable 

  • PhD in Pharmaceuticals Science

 

Location: South East

 

To apply please send your CV and a cover letter with your salary expectations to recruitment@gwpharm.com by close of business 19th December 2014.

Warehouse Supervisor

 

Permanent 

  

The Role

To supervise the receipt, storage and distribution materials and products across the site and dispatch of product and raw materials to customers and partners

 

Key Responsibilities

  • Supervision of all Warehouse activities
  • Receiving of raw materials from suppliers
  • Booking in of materials to be stored within the warehouse
  • Picking and delivery of materials to internal customers across the site
  • Receiving of finished product and storing in appropriate storage locations
  • Maintenance of stock records
  • Manage completion of raw material and finished goods cycle counting
  • Provide active support for six monthly stock checks
  • Provide Supply Chain Department support as required
  • Assist with commercial shipments to marketing partners.
  • The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job.
  • Supporting both domestic and international product shipment
  • Support for out of hours call outs for Supply Chain plant alarms

 

Essential Skills

  • Experience in a similar Supply Chain position
  • Knowledge of a broad-base of supply chain functions and disciplines
  • Pharmaceutical industry experience
  • Fork Truck Licence
  • High levels of self-motivation and exceptional commitment to the success of team members and the company
  • Excellent interpersonal and communication skills
  • Attention to detail and delivery of accurate data
  • Experience of IT systems and software including ERP software and MS Office software especially Excel

 

Location: South East 

 

To apply please send your CV with salary expectations to recruitment@gwpharm.com

By close of Business 8th December 2014

 

Deputy CRA Manager required in USA (Field Based)

 

FTC 12 months

 

The Role

  • To provide CRA resource for clinical trials from trial set up to database lock.
  • Line management and performance responsibility for assigned contract and freelance CRAs.

 

Key Responsibilities

  • Line management and supervision of assigned contract and freelance CRAs in mainland Europe.
  • Manage assigned CRA performance and identify training requirements to ensure clinical studies are reported within timelines and budgets.
  • Ensure CRAs have knowledge and understanding of all necessary procedures and regulations.
  • Report to CRA Manager/Clinical Operations Director/Senior Management on performance of assigned CRA team.
  • Input into clinical department SOPs/processes
  • The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job.

 

Essential Skills

  • Bachelor’s degree (BSc.) or equivalent in life science or allied health fields such as nursing, pharmacy or health science.
  • Experience in the pharmaceutical industry with senior CRA experience.
  • Ability to recruit appropriate personnel with required skills and knowledge.
  • Experience of line management
  • Has understanding of the regulatory process, including how this interacts with the clinical activities and processes, including safety reporting.
  • Knowledge of processes required of line managers.
  • Have a very high degree of accuracy and attention to detail with a proven track record for ensuring quality data.
  • Have strong leadership and negotiation skills.
  • Possess excellent verbal and written communication, interpersonal and organisational skills.
  • Flexible and adaptive approach to work.
  • Has developed understanding and increases knowledge of medical terminology common to therapeutic area(s).
  • Has good working knowledge of relevant GW SOP’s, ICH-GCP, EU Directive 2001/20/EC, Commission Directive 2005/28/EC and applicable regulatory guidelines.
  • Demonstrates and applies an understanding of the purpose of monitoring, including interpretation of the Declaration of Helsinki and the principles of Good Clinical Practice.
  • Ability to drive and be available for extensive travel including overnight stays, both domestically and internationally, as required.

 

Desirable Skills

  • Fluency in languages other than English
  • Previous experience in core GW therapeutic areas and/or studies using controlled medications
  • Competent with standard and job specific computer applications including Microsoft Office, SharePoint and Electronic Data Capture systems
  • Previous experience with risk-based monitoring approaches

 

Location:  Field-based, US. This role will involve travel throughout the United States of America

 

To apply please send your CV with salary expectations to recruitment@gwpharm.com

By close of business 8th December 2014

 

Deputy CRA Manager

 

FTC 12 months

 

The Role

  • To provide CRA resource for clinical trials from trial set up to database lock.
  • Line management and performance responsibility for assigned contract and freelance CRAs. 

Key Responsibilities

  • Line management and supervision of assigned contract and freelance CRAs in mainland Europe.
  • Manage assigned CRA performance and identify training requirements to ensure clinical studies are reported within timelines and budgets.
  • Ensure CRAs have knowledge and understanding of all necessary procedures and regulations.
  • Report to CRA Manager/Clinical Operations Director/Senior Management on performance of assigned CRA team.
  • Input into clinical department SOPs/processes
  • The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job. 

Essential Skills

  • Bachelor’s degree (BSc.) or equivalent in life science or allied health fields such as nursing, pharmacy or health science.
  • Experience in the pharmaceutical industry with senior CRA experience.
  • Ability to recruit appropriate personnel with required skills and knowledge.
  • Experience of line management
  • Has understanding of the regulatory process, including how this interacts with the clinical activities and processes, including safety reporting.
  • Knowledge of processes required of line managers.
  • Have a very high degree of accuracy and attention to detail with a proven track record for ensuring quality data.
  • Have strong leadership and negotiation skills.
  • Possess excellent verbal and written communication, interpersonal and organisational skills.
  • Flexible and adaptive approach to work.
  • Has developed understanding and increases knowledge of medical terminology common to therapeutic area(s).
  • Has good working knowledge of relevant GW SOP’s, ICH-GCP, EU Directive 2001/20/EC, Commission Directive 2005/28/EC and applicable regulatory guidelines.
  • Demonstrates and applies an understanding of the purpose of monitoring, including interpretation of the Declaration of Helsinki and the principles of Good Clinical Practice.
  • Ability to drive and be available for extensive travel including overnight stays, both domestically and internationally, as required.  

Desirable Skills

  • Fluency in languages other than English
  • Previous experience in core GW therapeutic areas and/or studies using controlled medications
  • Competent with standard and job specific computer applications including Microsoft Office, SharePoint and Electronic Data Capture systems
  • Previous experience with risk-based monitoring approaches

 

Location: Cambridge or Field-based, UK. This role will involve travel throughout the UK and Europe

 

To apply please send your CV with salary expectations to recruitment@gwpharm.com

By close of business 8th December 2014

 

Validation Contractor/Engineer/Consultant

 

1 Year Contract

 

An excellent opportunity has arisen to work in one of the most exciting areas of modern medicine within this innovative pharmaceutical company. 

 

GW Pharmaceuticals was founded in 1998 and is listed on both the NASDAQ Global Market (GWPH) and AIM, a market of the London Stock Exchange,. GW is licensed by the UK Home Office to work with a range of controlled drugs for medical research purposes. The Group's lead programme is the development of a product portfolio  of cannabinoid prescription medicines to meet patient needs in a wide range of therapeutic indications, including Sativex® Oromucosal Spray and Epidiolex® for childhood epilepsy.

 

GW has assembled a large in-house team with extensive experience in developing cannabinoids, medicines containing controlled substances, as well as plant-based prescription pharmaceutical products. GW maintains in-house control over all aspects of the cannabinoid product development process. GW also holds GMP manufacturing licences for the manufacture of pharmaceutical products for both clinical trials and commercial purposes

 

For details of GW’s current marketed product and international clinical research programme please refer to information on the company’s website: www.gwpharm.com .

 

The Role

We require a Validation Contractor who can support our inspection readiness programmes, in particular for an FDA Pre-Approval Inspection, which will include the commissioning and qualification of new and existing facilities.

Reporting through the Validation Specialist to the Site Quality Assurance Manager and working from the manufacturing facilities in the south-east, this is a highly interactive role requiring a strong attention to detail in a rapidly changing environment. It also requires analytical thinking, high energy excellent organisational and communication skills, and the ability to operate effectively within a busy team whilst building relationships within the organisation, and acting as an advocate for Validation.

 

Key Responsibilities

  • Generation of key Validation procedures for manufacturing and packaging operations, including qualification of equipment, cleaning validation and process validation
  • Ability to train staff in procedures
  • Support for GMP and PAI readiness requirements relating to Process Validation and Cleaning Validation 

 

Essential Skills

  • Excellence in writing of Validation procedures
  • Support for GMP and PAI readiness requirements relating to Process Validation and Cleaning Validation
  • Ability to train staff in procedures
  • Support of projects by execution and review of validation protocols and writing reports as required
  • Ability to work to tight, planned timelines and manage deliverables
  • Knowledge of risk assessment approach to validation strategy

 

Qualifications/experience required:

  • A Biological/Science Degree or equivalent is preferred
  • Proven experience in a GMP environment and in validation
  • Experience/Awareness of Validation Lifecycle and specifically FDA Process Validation Guidance
  • Experience/Awareness of ISPE Commissioning and Qualification approach
  • Experience of project validation execution and report writing
  • Excellent interpersonal skills and the ability to work as part of a team or independently
  • Excellent attention to detail
  • Able to self-manage time to complete tasks to a high level  to agreed deadlines
  • Driving license would be preferred
  • Proof of eligibility to work/reside in the UK will be required 

Location: South East 

 

To apply please send your CV with salary expectations to recruitment@gwpharm.com

 

IT Compliance Specialist

 

Permanent

 

An excellent opportunity has arisen to work in one of the most exciting areas of modern medicine within this innovative pharmaceutical company. 

 

GW Pharmaceuticals was founded in 1998 and is listed on both the NASDAQ Global Market (GWPH) and AIM, a market of the London Stock Exchange,. GW is licensed by the UK Home Office to work with a range of controlled drugs for medical research purposes. The Group's lead programme is the development of a product portfolio of cannabinoid prescription medicines to meet patient needs in a wide range of therapeutic indications, including Sativex® Oromucosal Spray and Epidiolex® for childhood epilepsy.

 

GW has assembled a large in-house team with extensive experience in developing cannabinoids, medicines containing controlled substances, as well as plant-based prescription pharmaceutical products. GW maintains in-house control over all aspects of the cannabinoid product development process. GW also holds GMP manufacturing licences for the manufacture of pharmaceutical products for both clinical trials and commercial purposes

 

For details of GW’s current marketed product and international clinical research programme please refer to information on the company’s website: www.gwpharm.com.

 

The Role

Reporting to the Head of IT, you will be responsible for providing lead support for IT and CSV compliance activities at the Cambridge office. You will write and execute change and error management, compliance and validation documents and Standard Operating Procedures (SOPs) and develop process improvements to maintain an effective compliant IT group.

 

With a proven background in IT compliance, you will provide technical input into change and installation documents, often involved in the required steps to implement them.

 

Key Responsibilities

The successful Applicant will be responsible for:

  • Writing new and developing existing Standard Operating Procedures (SOPs) and guidelines
  • Preparing responses and identifying remedies to issues arising from internal and external audits, risk assessments and testing
  • Providing lead IT and compliance support for the ARISg System (Pharmacovigilance Database)
  • Evaluating the effectiveness of IT processes, records and written procedures and implementing change to improve their performance
  • Producing and maintaining recordsConsulting computer users to ascertain needs and to ensure that facilities meet user and project requirements
  • Providing users with appropriate support and advice
  • Keeping up to date with the latest technologies and regulations
  • Interfacing with IT users/contractors/developers and suppliers
  • Project based work to continually improve the companies effectiveness.

 

Essential Skills

  • Broad understanding and working knowledge of the application of pharmaceutical & financial regulations to IT including GCP, GMP, GAMP, FDA 21 CFR Part 11 and SOX.
  • Pharmaceutical industry experience, including relevant experience in a role directly associated with pharmaceutical computer systems validation/qualification practices.
  • Highly computer literate with experience of the system design lifecycle, and development of qualification documentation in a regulated environment.
  • Experience of interfacing with IT users/contractors/developers and/or suppliers.
  • Project management.
  • First rate technical writing abilities.
  • Excellent analytical and problem solving skills.
  • Can manage crisis situations, which may involve complex technical hardware or software problems.

Ideally, you will be familiar with:

  • ARISg (version 6.3) Drug Safety Database or similar
  • Microsoft Windows Desktop
  • Microsoft Windows Operating Systems, MS Office tools and MS Server (2003 onwards)
  • Hyper-V/Virtual Computer Environments
  • Java

 

Location: Cambridge

 

To apply please send your CV with salary expectations to recruitment@gwpharm.com

By close of business 1st December 2014

 

Commercial Contract Manufacturing Manager

 

GW is an expanding pharmaceutical company and we are looking for a Commercial Contract Manufacturing Manager to join our Manufacturing Operations group based in South East England.

 

The role is a key position within the company requiring management of commercial operations with our external contract manufacturers and suppliers.

You will also manage the outsourcing of activities associated with API Manufacture and Drug Product operations from both a Technical and Commercial perspective.

 

Reporting in to the Site Director you will be need to:

Deliver external manufacturing plans on time and in full to the quality specified in the technical agreements and on budgeted cost of goods.

Manage approved budget and expenses for external manufacturing operations. To manage the commercial contracts

Ensure outsourcing and contract manufacturers are fully compliant with cGxP and support internal and external audits. Ensure facilities are ready to support regulatory inspections (FDA and MHRA)

Ensure contract companies meet the necessary standards and company policy requirements for Environmental, Health & Safety

Develop Operational Excellence initiatives and adopt best practices to make productivity and cost of goods improvements with external suppliers

To work with suppliers to develop Key Performance Metrics  

To act as the main point of contact between external partners and site functional groups. To ensure good and timely communication with all functional areas and management

To help manage change controls, alerts, deviations, complaints, OOS and ensure these are executed and closed out in a timely manner. To ensure we have a Quality and or a Technical Agreement in place with all our external suppliers and ensure compliance with the requirements.

To oversee troubleshooting and resolution of product quality and technical problems with external contract suppliers.

 

 Knowledge, Skills and Experience Required:

A background in Manufacturing or Supply Chain is essential.

A science or engineering background would be preferable, qualification to degree standard would be an advantage

Will have a demonstrated track record with relevant experience working in a regulated industry.

Proven Commercial Operations experience.

  

This is a full time, permanent position, based in South East England.

GW is fully committed to achieving equality of opportunity in all its employment practices, policies and procedures irrespective of their race, ethnic origin, religion, colour, age, gender, sexual orientation, nationality, disability, or marital status. The Company does not tolerate any harassment or discrimination and every employee is highly valued and their rights and dignity are respected. The equal opportunities policy covers all permanent and temporary employees (including non-executive directors), all job applicants, agency staff, associates, consultants and contractors.