Quality Assurance Manager (GMP)
Cambridge
£65,000 max + benefits
THE COMPANY
My client are a commercial stage biotechnology company based in Cambridge who due to company growth and on-going expansion are currently seeking an experienced Quality Manager to join their business on a permanent working basis. This role would be the ideal next step for an experienced Team Leader or Senior Quality specialist/Officer who has knowledge and understanding of CMO or Supplier Management.
If you are looking for the opportunity to develop yourself, and grow with an organisation which will support you through this, whilst taking on a new challenge, learning new skills and feel comfortable taking on new responsibilities, then this could be just the opening for you.
THE ROLE
The role will be responsible for the oversight and execution of quality related activities through all stages of clinical development to global commercialisation. Responsibilities will include leading the development and implementation of policies, procedures and protocols to control GMP activities, implementation of GMP standards and on-going compliance initiatives and regulations. The role will obviously involve interaction with global colleagues, internal stakeholders and external suppliers.
Other key responsibilities will include but not be limited to:
• Serve as GMP Quality SME for assigned programs.
- Develop and follow procedures for the oversight of quality aspects of pharmaceutical development in an outsourcing environment, including the quality aspects of process and formulation development, manufacturing, analytical testing, packaging, product release and associated stability programs.
- Perform quality activities such as: validation protocols, report, review and approval, specification review and approval, batch record review, approval and release to ensure timely delivery of finished products to support the clinical development plan as well as commercial sales plan.
- Oversee supplier quality management activities for assigned suppliers. Oversight will include confirmation of compliance, management/conduct of quality audits and inspection readiness activities and appropriate resolution of CAPA plans as required.
- Perform and participate in internal audits as assigned.
Successful applicants must be able to demonstrate excellent quality experience as well as 5+ years of hands on QA/QMS experience ideally within a manufacturing or CMO environment.
You must also be able to show:
• A demonstrated ability to develop and implement procedures which ensure compliance to GMP and regulatory standards.
• Demonstrated audit conduct and management experience.
• Demonstrated knowledge, understanding and application of GMP guidelines and regulations.
• Fluent English communications skills (written & spoken).
- Considerable knowledge of drug development process, FDA,EMA,MHRA, ICH guidelines and GMPs.
To apply for this role, please call Bob Beevers at CPL Life Sciences on +44 7890 551 627 or send an updated version of your CV via email to [email protected]
If this role is not for you, we do operate a bonus referral scheme should we go on to successfully place someone that you recommend to us so please feel free to share these details within your network.