Senior QA Specialist, GMP & Compliance (Leiden)

Biopharma Asia; Nederland; Hybrid; EUR 55,000 - 87,000; Full time

Job summary

Johnson & Johnson Innovative Medicine Biologics in Leiden, the Netherlands, seeks an Experienced QA Specialist to strengthen GMP compliance, product quality, and operational excellence in a pharma manufacturing setting.

You will partner with Operations, Quality Control, Manufacturing and other functions to ensure cGMP compliance, lead investigations, and support change controls and risk management in a dynamic environment.

Qualifications

• Bachelor's degree in Bioscience, Chemistry, Pharmacy, or related discipline with 4–6 years of relevant experience.
• Master's degree in Bioscience, Chemistry, Pharmacy, or related discipline with 2–4 years of relevant experience.
• Experience with GMP regulations and quality systems.

Responsibilities

• Provide timely and practical quality guidance on cGMP and quality-related topics.
• Lead site investigations and ensure CAPAs are implemented effectively within agreed timelines.
• Support preparation activities for regulatory inspections, including FDA and EMA inspections.
• Reviewing, assessing, and approving deviation-related change controls.
• Partner with site colleagues to ensure projects and changes comply with cGMP requirements.
• Assess and approve study protocols and reports, including validation and stability studies.
• Participate in Quality Risk Management activities and root cause investigations.
• Contribute to quality and compliance initiatives for continuous improvement across the organization.

Skills

Dutch & English communication

GMP knowledge

QA experience in pharma

Quality investigations & root cause

Lean tools & process excellence

Analytical problem solving

Cross-functional collaboration

AI concepts awareness

Education

Bachelor's degree in Bioscience, Chemistry or Pharmacy

Master's degree in Bioscience, Chemistry or Pharmacy

Job description

Johnson & Johnson Innovative Medicine Biologics in Leiden, the Netherlands, seeks an Experienced QA Specialist to strengthen GMP compliance, product quality, and operational excellence in a pharma manufacturing setting.

You will partner with Operations, Quality Control, Manufacturing and other functions to ensure cGMP compliance, lead investigations, and support change controls and risk management in a dynamic environment.