Senior QA Director - GCP/GVP

Job title : Senior QA Director - GCP/GVP
Location : Munich
Job type : Permanent
Senior QA Director - GCP/GVP

This is a fantastic position with a global life science company working at the forefront of biopharmaceutical medicines. They have existing products on the market and a strong pipeline of products in development that offer life-changing therapies to patients across the world. This role gives you the chance to influence GCP and GVP QA and ensure the continued delivery of the highest quality products and service to millions of patients.

Salary & Benefits:

Excellent salary and benefits package on offer. Full details on request.

Role and responsibilities:

*Manage the Quality Assurance team responsible for Good Clinical and Good Pharmacovigilance Practice (GCP/GVP)
*Set up the annual audit plan and subsequently lead the preparation, performance and follow-up of audits at CROs, service providers, external laboratories, clinical trial sites and in house systems
*Host inspections from healthcare authorities
*Provide strong team leadership in the implementation and tracking of suitable KPIs to measure effectiveness of GCP and GVP related Quality Systems
*Drive continuous improvement initiatives of the GCP/GVP Quality System
*Ensure timely delivery of GCP/GVP QA audits, metrics, CAPAs
*Write and review QA SOPs
*Lead and manage interactions with external CROs and PV services providers for all matters relating to QA
*Responsibility to ensure that the GCP/GVP QA team acts communicates coherently and regularly with other relevant internal departments (e.g. Clinical Operations and Development, Drug Safety, Pharmacovigilance)

Requires skills and qualifications:

*Scientific Degree with at least of 12 years' experience in GCP and GVP Quality Assurance within pharmaceutical or biotech industry
*Solid track record in hosting authority inspections including pre-approval inspections from European authorities and FDA
*Minimum of 8 years' experience in team management of GCP/GVP QA professionals
*Excellent and updated knowledge in international regulations and guidelines (EU / FDA regulations, ICH-GCP etc.)
*Deep knowledge in GCP and GVP compliance as well as in conduct of international clinical trials
*Significant understanding of drug development process and the Global Regulatory Requirements
*Ability to travel

To apply for this position and put yourself under immediate consideration, send your CV to john.spring@secpharma.com or call +44 (0) 207 255 6650