QC Director / Head of QC
Start: September 2021 (flexible)
The Quality Control (QC) department is responsible for monitoring the quality of our AAV-based products, and the quality of the raw materials and starting materials used. QC is also responsible for execution of the Environmental Monitoring (EM) program in place to monitor the manufacturing environment (clean rooms). These activities are all performed in accordance with cGMP guidelines, and are supported by departmental and inter-departmental policies and standard operating procedures.
Key result areas (major duties, accountabilities and responsibilities)
(General departmental, compliance)
- Coordinating day-to-day management of the QC department, including high-level planning of activities and resources, guidance/performance review of key functions within QC, and maintaining or initiating communication lines with other departments within the company. Key activities:
- In-house testing activities to ensure product quality (based on chemical-physical, biological, biochemical, microbiological or other test methods) of raw materials, starting materials, intermediates and final products manufactured within the GMP production environment
- Environmental monitoring of the GMP production environment
- Outsourcing activities
- Transfer activities
- Maintaining department structure and ensuring continued development/training of staff members
- Ensuring compliance to national and international regulations and pharmacopoeia, and making continuous improvements accordingly
- Managing the implementation/maintenance/continuous improvement of the Quality System, which involves up to date documentation (SOP’s), test method descriptions (AIMs) and related method and equipment validation documentation, training profiles and records for trained and skilled personnel, qualified and calibrated equipment, data management system(s), etc.
- Authorization and/or review of documentation where applicable
- Oversight and ensuring timely progression of documentation related to all quality indicators: (planned) deviations, change controls, and out-of-specifications
- Oversight of major project milestones and translating these into QC deliverables: mediate communication within QC, ensure appropriate planning + priority setting, monitor progression
- Master in Biology, Chemistry, Biotechnology, or equivalent
- Several years (>5) of professional experience (in similar pharmaceutical environment/GMP/QC)
- Expert knowledge of EudraLex, CFR, ICH guidelines and industry regulations
- Experience in quality systems development and continuous improvement
- Analytical background and know-how (preferably related to biological products: virus- or vaccine-based)
- Experience with QC related quality systems and data management systems
- Experience with (>2 years) managing a QC team of >6 staff
- Strong people management skills
- Strong communication skills; fluent in English, both written and verbal
- Team player
- Decision maker, goal orientated
- Ability to cope with many topics in parallel, to cope with strict time lines and to handle pressure
- Ability to work in cross-functional teams
Do you have questions? Or do you know someone who would be interested in this role?
Do not hesitate and contact me by applying to this position!