QA Manager - GCP
A UK-based biopharmaceutical company is seeking to hire a QA Manager - GCP to their office in Cambridge. The company specialises in treatments for neurological diseases and are proud of their expanding product portfolio. This is an exciting opportunity to work with a company and provide real expertise and skill to their QA team.
- Contribute to the planning and execution of all audit schedules, including but not limited to internal processes, Vendor, clinical investigational site, and pharmacovigilance activities.
- Assist in the resourcing and management of CQA professionals to meet the needs of the relevant audit programmes.
- Support the deployment of regulatory inspection readiness plans, as well as fulfilling assigned responsibilities during GCP/GPvP regulatory authority inspections.
- Manage and ensure direct report(s) are appropriately trained and have Personal Development Plans in line with departmental goals.
- Promote a GxP compliant environment for the conduct of GW clinical studies.
- Oversee the development of departmental processes and procedures as well as reviewing and providing input on cross-functional processes and procedures.
- Represent the Quality Director on assigned GW product Programme Team and provide updates on quality activities related to the clinical programme to Clinical Study Teams.
- Assign a CQA representative for each clinical study (and non-interventional study where appropriate) in designated portfolio and provide clinical quality oversight of the portfolio.
- Provide GCP/GLP/regulatory advice to product Program and Clinical Study Teams as appropriate.
- Contribute to the planning and execution of all audit schedules, including, but not limited to, those for internal process, Vendor, clinical investigational site, and pharmacovigilance activities for assigned Programme.
- Manage and ensure direct reports are appropriately trained and have Personal Development Plans in line with departmental goals.
- Act as an ambassador to protect the rights and well-being of all subjects participating in drug development activities on behalf of the company.
- Verify that data integrity principles are adhered to within Research and Development activities.
- Promote quality by design awareness amongst company personnel and develop and maintain company GCP, cGLP, GLP, GPvP, and other quality standards by means of training, review, advice, and guidance services.
- Strategically assess and report to the Director, CQA, and Senior Management the risk of any critical or major audit finding identified at any study specific, Vendor, Marketing Partner, or internal process/system audit.
- Prepare for and support Sponsor and Clinical Investigator inspections/external audits conducted by national and international regulatory authorities (RA) and other external bodies such as marketing partners.
- Represent CQA in relevant meetings or ensure a nominee is assigned.
- Conduct any other quality related activities required by Senior Quality Management.
Skills and Requirements:
- Bachelor's degree or equivalent in a scientific discipline.
- Extensive relevant clinical/preclinical research experience in a healthcare company, with demonstrated knowledge and experience of auditing/inspection techniques, including specific, vendors, internal process/system, pharmacovigilance activities, and regulatory submissions.
- Experience of related quality assurance principles applicable to clinical trials
- Knowledge and experience of working to pharmaceutical regulatory standards in clinical research and knowledge of international regulatory requirements for product registration.
- Detailed knowledge of GCP and GCLP.
- Knowledge of GLP and GVP international regulations, guidance, and GMP international regulations as related to clinical trials supplies, with the ability to apply this knowledge to resolve day-to-day issues and steer the progress of the company compliance improvements.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Katty Maia at +44 2038543317 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.