Senior GMP Scientist - Medicines Compliance & Inspections

European Medicines Agency; Amsterdam; On-site; EUR 97,000 - 117,000; Full time

Benefits offered by this job

Relocation assistance

Excellent health insurance

Education allowances

Job summary

European Medicines Agency in Amsterdam seeks a Senior Scientific Specialist (GMP) to lead GMP expertise and regulatory support across the lifecycle of medicines. You will coordinate GMP inspections, contribute to guideline development, and collaborate with EU and international partners.

We value strong communication, strategic thinking, and the ability to work autonomously within a team of GMP professionals in a forward-looking Inspections Office.

Qualifications

• University degree (minimum four years) in Life Science or General Sciences (biology, chemistry, biochemistry, pharmacy, engineering).
• At least 9 years of relevant professional experience after degree for the first condition.
• Or university degree (minimum three years) with at least 10 years of relevant professional experience.
• Experience in GMP manufacturing or regulation is highly desirable.

Responsibilities

• Provide GMP regulatory expertise for review of manufacturing aspects for human and veterinary medicines across product lifecycle.
• Coordinate GMP and PMF inspections pre- and post-approval.
• Assess quality defects, recalls, and GMP non-compliance within EMA and EU network.
• Contribute to GMP guideline development and regulatory input to working groups.
• Present inspection topics at internal/external forums and represent EMA externally.

Job description

European Medicines Agency in Amsterdam seeks a Senior Scientific Specialist (GMP) to lead GMP expertise and regulatory support across the lifecycle of medicines. You will coordinate GMP inspections, contribute to guideline development, and collaborate with EU and international partners.

We value strong communication, strategic thinking, and the ability to work autonomously within a team of GMP professionals in a forward-looking Inspections Office.