Senior Product Quality Lead
The Company
A global Contract Manufacturing Organisation (CMO), who specialise in producing clinical trial batches for Pharmaceutical and Biotechnology companies all over the world, is recruiting a Senior Product Leader at their site in the Netherlands. Not only do they produce their own products but they are responsible for some of the most innovative and exciting drugs being manufactured for patients by some of the globes leading companies.
They are rapidly expanding their product and client portfolio and are looking for ambitious candidates to develop their professional and personal careers. They have the highest reputation on Quality and are only considering candidates who would live up to their standards.
The Role
- Responsible for final disposition to customers of cell banks and bulk pharmaceutical products and for managing all activities to enable this disposition in an efficient and cGMP compliant way according the agreements made with the project manager, the client and according to regulatory expectations. Proposes and implements improvements related to quality and compliance.
- Advise to project organization and customers on all relevant cGMP matters and assure appropriate cGMP level of project activities.
- Serves as quality advisor for investigations and recommends actions to ensure continued compliance and avoiding recurrence.
- Reviews and approves cGMP documents associated to the product in compliance with local and corporate SOPs and applicable legislation.
- Approves investigations assuring that they are complete, accurate, technically justified with the required documented evidence including risk assessment.
- Evaluates and approves Changes associated with the product.
- Plan, perform and monitor in collaboration with the project manager QA activities within the project to ensure results are according the agreement and regulatory expectations.
- Provides assistance and guidance with regard to the Quality Systems to other departments. Proposes and implements improvements to these systems.
- In-direct supervision of other Product Quality Leaders in the group (4-5 people).
Experience
- Small or Large molecule background
- Quality Management Systems
- GMP
- Project Management
- Fluent in English
If this a position you are interested, please submit an up-to-date copy of your CV to;
Or Call;
+0044 203 758 8831
