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Head of Quality Control
15 MAR '23: This Leiden-based organisation comprises a state-of-the-art facility and expert knowledge on the development, production, and commercialisation of Cell and Gene Therapies. They help academic and industrial Cell & Gene Therapy developers enter the clinical stage by combining the required expertise from various departments in a brand-new development & GMP manufacturing facility. They enable the next generation of therapies by translating research programs into actionable health solutions for patients.
Details
Biotechnical
Quality/RA
Netherlands
40 hours per week
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About your role
This is how you will make the difference
As Head of Quality Control, you are responsible for establishing and managing all analytical development and QC-related activities, such as cleanliness compliance of the classified facility and other related systems as per the scope of EMA and FDA ATMP regulatory requirements, phase-appropriate development and validation of analytical methods, in-process, final product and stability testing, the release of incoming goods, Environmental Monitoring (EM), outsourcing, and handling of quality events and change records. Other responsibilities include maintaining a team of trained staff and QC-related facilities and equipment. Additionally, implementing and continuously improving associated documentation in the Quality System, including review and approval of study plans, reports, test methods, procedures and GMP-related documentation.
what's needed
What you bring
To be successful in this role, you have/are:
- A Master's Degree in Biology, Biochemistry or a related field with five years of relevant working experience in a similar management position;
- Demonstrated leadership experience with managing teams, including indirect supervision;
- Background and know-how in microbiological, biochemical and a broader range of analytical assays;
- Solid understanding and knowledge of applicable regulatory requirements and GMP guidelines;
- Fluent in English.
What we offer
What's in it for you
As Head of Quality Control, you receive a competitive salary and an excellent pension plan. Not to mention the many opportunities and exciting dynamics of a scale-up environment and GMP training by our expert team. A standard full-time position at this organisation is 36 hours. In addition to your salary, you will receive:
- 13th-month payment;
- 8% holiday allowance.
You will join the team at an early stage, giving you the unique opportunity to co-define the company and contribute to the organisation's establishment. Your expertise is critical for their successful launch, meaning you will enjoy a lot of responsibility and impact regarding key decisions.
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