Head of Quality

The organisation

For our client, a well-funded CDMO at the forefront of innovation, committed to delivering groundbreaking solutions in the pharmaceutical industry, we are currently looking for their Head of Quality to join the team and further structure the department while fostering their growth in the Leiden Bioscience park.

The position

The organisation operates on values like integrity, authenticity, entrepreneurship, quality, and trust which drive them to set new standards in every aspect of their work. In this role you will head the entire Quality department, covering both QA & QC, but will also include further optimising the fully operational Quality Management System and Audit program. In this role you report directly to the CEO and your responsibilities include designing, implementing, and maintaining the quality management system, ensuring compliance with GMP and regulations, conducting audits, and efficiently handling quality issues. You will also play a vital role in supporting business development activities and client interactions, contributing to our continued success.

Candidate profile

With a Master or Ph.D. in a pharmaceutical direction and extensive experience (10+ years the world of pharma/biotech) the right candidate brings along:

• Proficient in cGMPs and EMA regulations and expertise in microbiological, biochemical, and analytical assays;
• 5 years auditing experience, preferably in ATMPs;
• Knowledge of Cell- and Gene Therapy GMP guidelines;
• 3 years of CMO/supplier management experience;
• 5 years of progressive and proven to be successful managerial experience;
• Strong English communication skills and willingness to travel occasionally for audits.

The offer

Next to the possibility of joining one of the most bespoken scale-ups on Leiden’s Bioscience park and spearheading the quality teams while strategically aligning yourself with the coming growth, this organisation offers a competitive base salary with the following benefits:

• Fulltime is 36 hours;
• Fixed 13th month;
• Premium free pension plan;
• Flexible employment scheme.

Interested?

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