Head of Quality Control (biotechnical)

The organisation

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.

The position

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.

Candidate profile

• 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.

The offer

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. 

Interested?

You can apply to this position by using the link below.