Our client is a well‑established pharmaceutical organisation operating within a highly regulated GMP environment, supporting global manufacturing and supply activities for complex medicinal products. The organisation places strong emphasis on quality governance, inspection readiness, and regulatory compliance as critical elements of patient safety.
Quality Control operations are embedded within mature quality systems and aligned with European and international regulatory expectations, supporting both commercial manufacturing and advanced development programmes. The environment is scientifically demanding and characterised by close collaboration across Quality, Manufacturing, and Development functions.
The role combines scientific accountability, GMP oversight, and people leadership, ensuring that all bioanalytical testing activities are conducted in compliance with regulatory requirements, marketing authorisation documentation, and current scientific standards.
You will be responsible for the design, execution, and continuous improvement of QC bioanalytical processes, while maintaining inspection readiness and representing the function during audits and regulatory inspections. The position works closely with Quality Assurance, Manufacturing, Development, and Qualified Persons.
Fulfilment of all responsibilities of the Head of Quality Control in accordance with EU‑GMP and AMWHV (§12)
Scientific review and approval of analytical results supporting manufacturing and release processes
Evaluation and approval of deviations, OOS/OOT/OOE investigations, CAPAs, change controls, and APR/PQR content
Planning and management of laboratory resources, capacity, priorities, and project activities
Representation of the bioanalytical QC function during internal and external audits and regulatory inspections
Leadership, development, and performance management of the laboratory team
Very good English and German kills
Long‑term opportunity within a stable and compliance‑driven organisation