Head of Quality (QA/QC) and QP

The organisation

For our client, a well-funded and fast-paced developing 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 into the CEO and your responsibilities include the strategic oversight of (further) 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 their continued success. The Head of Quality within this organisation is a true collaborator, standing alongside colleagues to work towards solutions together. Your expertise in Quality Assurance & Quality Control activities shall be a key contributor to the organisation it's success.

Candidate profile

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

• Proficient in cGMPs and EMA/FDA regulations and exposure to microbiological, biochemical, and analytical assays;
• 5 years auditing experience, preferably in ATMPs;
• Eligible to perform the duties of a Qualified Person;
• 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:  

• A fulltime working week of 36 hours;
• Fixed 13th month;
• Strategic influence into the course of the organisation;
• Premium free pension plan;
• Flexible employment scheme.

Interested?

You are invited to apply for this position by following the link below.