Currently recruiting for a Quality Assurance Manager on behalf of a leading pharmaceutical client based in Cambridge. As a key manager within the multi-disciplined company QA team you will utilise your extensive GMP knowledge and excellent leadership and communication skills to oversee the compliance programme for the manufacturing and development function, including managing the Key Performance Indicators and overseeing the audit programme including internal systems, external suppliers, documentation and contractor audits.

Experience

• Candidates should have a minimum of 5 year's proven management experience in an MHRA/FDA regulated environment, with an excellent working knowledge of current ICH, EU and US regulatory requirements and their implementation.
• Experience with natural products, particularly botanicals, would be advantageous. QP status is essential and eligibility and experience must cover release of both Commercial Products and Investigational Medicinal Products for solid and liquid dose forms as well as understanding the requirements and responsibilities relating to Active Pharmaceutical Ingredient release.
• Reporting to the Site Head of Quality and based at the company’s main manufacturing site, this is a highly interactive and influential role, requiring self-reliance, effective strategic thinking and planning skills, the ability to network, lead a busy but well-established and confident team, and build successful interfaces both internally and externally.
• Excellent leadership, negotiation and influencing skills are absolutely essential.

Essential

• Ideally a bioscience degree or chemistry/pharmacy qualification
• Eligible to be named as a Qualified Person on both MIA and MIA(IMP) Licences
• Broad experience in development and commercial GMP
• Must have worked in a GMP or regulatory environment for at least five years at management level
• A working knowledge of US FDA cGMP requirements would be advantageous
• Experience of successfully managing a team
• A full clean driving licence is required