Senior Manager, Quality (GDP)
Proclinical is seeking a highly motivated individual to join the Quality Assurance team as a Senior Manager, Quality GDP. This UK based role will ensure that products are distributed safely.
- Provide leadership and resource management support to Corporate Quality and the designated Affiliate
- Ensure that Global Quality Standards Operating Procedures (SOPs) are implemented in accordance with US, EMA, and local PV guidelines
- Coordinate Self-inspections and internal auditing resource to assess site compliance on a regular basis. Perform self-inspections
- Manage the review and implementation of Quality Improvement/remediation plans for the Affiliate identified through Corporate as well as internal GxP audits
- In collaboration with the Corporate Quality organization, weigh and communicate quality and compliance risks as appropriate
- Act as Quality liaison between the local operational groups and Corporate Quality for GDP/GXP/PV functions and activities.
- Partner with local, regional and global operational groups to foster a proactive approach to compliance.
- Approve any subcontracted activities which may impact on GDP
- Ensure that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place
Skills and Requirements
- Bachelor's Degree in physical /life science or pharmacy; Advanced degree preferable Compliance and management experience in pharmaceutical/ biotech industry.
- Eligible to act as Responsible Person named on the UK Wholesale Dealers Authorisation (WDA)
- Thorough knowledge of applicable local and global regulatory requirements required for GDP, GXP compliance.
- Good knowledge of government regulations, laws and guidelines pertaining to GXP and Pharmacovigilance required
- Experience in using computerized system for Change Control, Deviation and CAPA management Education
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 Josh Godden on +44 203 854 0101 or upload your CV on our website - www.proclinical.com/send-cv