Cpl Life Sciences is currently partnering with a leading biotechnology company based in Central London to recruit a QC Validation Manager on a 12-month fixed-term contract. This is an exciting opportunity to play a key role in ensuring the quality and compliance of analytical test methods used in manufacturing processes.
The successful candidate will oversee the full lifecycle management of analytical equipment and materials, driving method validation and qualification activities in line with regulatory standards.
Key Responsibilities:
Lead the validation and development of analytical test methods.
Act as Subject Matter Expert (SME) for lifecycle management of assays, equipment, and materials.
Prepare and review qualification and validation documentation.
Ensure departmental adherence to regulatory and compliance requirements, including GMP and GDP.
Manage the implementation and project lifecycle of new test methods.
Collaborate with internal and external stakeholders to support testing and validation needs.
Deliver training and development initiatives across the quality control team.
Maintain and improve the Quality Management System (QMS).
Monitor and report on Key Performance Indicators (KPIs).
Provide support on CAPAs, change controls, and audit-related actions.
Candidate Requirements:
Degree or equivalent experience in a relevant scientific field (e.g. pharmaceuticals, biologics, or biotechnology).
Proven experience in a QC validation role within a regulated environment.
Strong project management and team leadership skills.
Demonstrated ability to work independently and deliver results efficiently.
Excellent understanding of EU and FDA regulations and industry standards (GMP, GLP, GCP).
Proficient in Microsoft Office and other relevant IT systems.