Clinical Qualified Person

Do you want to be part of a world wide organization recognized as World's Best Workplace with the mission of saving patients through advanced biotech technologies?

Our client's products reach over 10 million patients worldwide, that is why we are supporting them in looking for a Clinical Qualified Person to support a rich team in Breda that works on quality processes on time, so new products can be received, processed, released, and shipped to the market.

MAIN TASKS:

• Ensure clinical quality and patient safety by releasing Finished Drug Product & Inspected Drug Product for global markets, adhering to regulatory and quality standards.
• Serve as the QA lead for clinical product lifecycle management, including change control assessment, review, and approval for new and existing products.
• Provide clinical quality oversight and guidance to cross-functional teams (Quality, Production, Supply Chain, etc.) to ensure compliance with GxP and internal quality standards.
• Assess, approve, and own deviations, CAPAs, and change controls, ensuring robust root cause analysis and risk mitigation in alignment with clinical and regulatory expectations.
• Lead and participate in GMP/GCP audits and regulatory inspections, ensuring adherence to clinical and pharmaceutical quality requirements.
• Author, review, and approve quality documentation (SOPs, risk assessments, training materials) to support clinical and commercial manufacturing.
• Drive global quality initiatives and represent the site in implementing clinical quality standards and compliance with evolving regulations.
• Support continuous improvement in clinical quality systems, including participation in product launch teams and process optimization.
• Review and approve QP declarations, regulatory filings, and Quality Agreements, ensuring alignment with clinical and commercial requirements.

REQUIREMENTS:

• Master's in science in Pharmacy or Lifesciences (mandatory).
• Knowledgeable and skilled to fulfill the requirements of EU directive 2001/83/EC article 49 (Qualified Person).
• Experience in Clinical Quality within the pharmaceutical, biotechnology, or medical devices industry.
• Acquired practical experience in Good Manufacturing Practice (GMP) over at least 2 years.

Salary range open depending on experience + bonus structure, 13th month, holiday allowance and collective health insurance.