Senior scientific specialist gmp Vacatures

Over de vacature

The European Medicines Agency (EMA) is located in Amsterdam, the Netherlands. Serving a population of 500 million citizens, we promote and protect public and animal health in EU Member States, as well as the countries of the European Economic Area, by ensuring that all medicines available on the EU market are safe, effective and of high quality.

Within the EMA Inspections Office, the Good Manufacturing Practice (GMP) workstream is at the forefront of helping to ensure that medicines are manufactured in compliance with GMP standards, while supporting access to innovative therapies for patients and animals.

The workstream contributes to strategic initiatives such as GMP guideline development, technical advice relating to the implementation of legislation, inspection coordination, quality defect and non-compliance assessments and GMP input to marketing authorisation activities. It also supports the Good Manufacturing and Distribution Practice (GMDP) Inspectors' Working Group (IWG), representing inspection topics internally and externally and in international collaboration.

You will join the EMA Inspections Office, a team of over 30 compliance professionals across GxP disciplines, working alongside leading GMP and regulatory experts in a collaborative, professional and forward-looking environment.

The Agency is looking to recruit a Senior Scientific Specialist (GMP), who will provide scientific specialist expertise, coordination and regulatory support on manufacturing and GMP matters for human and veterinary medicines across the life-cycle of the medicinal product.

This role suits a motivated professional with strong GMP expertise, a broad understanding of the product lifecycle and the ability to balance technical knowledge with strategic thinking. You will use your communication and organisation skills to drive topics forward, working both autonomously and in a team, ensuring the views of stakeholders are heard while contributing your own expertise. You will help shape GMP guidance across the EU, represent inspection topics internally and externally, and work with international partners.

In this job you will:

• Provide scientific specialist expertise, coordination and regulatory support to the review of manufacturing aspects for human and veterinary medicines and their supply chains across the life-cycle of the medicinal product (e.g. evaluation of marketing authorisations and post-authorisation variations and line extensions and scientific advice).
• Coordinate pre-approval and post-approval GMP and Plasma Master File (PMF) inspections.
• Coordinate the assessment of quality defects, recalls, and notifications of GMP non-compliance, within EMA and within the EU regulatory network and with international partners when required.
• Contribute to and coordinate scientific and regulatory guideline development in the area of manufacturing, including providing scientific and regulatory input to the GMDP Inspectors' Working Group, supporting the building of consensus among members of guideline drafting groups and contributing to the implementation of new legislation and guidelines, whilst keeping overall objectives to protect patient and animal safety in mind.
• Support collaboration with other regulatory working parties within the EU (e.g. Quality Working Party/Biologics Working Party) and international co-operation on manufacturing and inspection related topics, including the exchange of compliance information with international partners, and promoting inspection reliance.
• Present inspection topics at internal and external fora (e.g. to EMA management, to the GMDP IWG and at external conferences), acting as an ambassador for the Inspections Office.

Key details

• Deadline for applications: 22 November 2026 at 23.59 CET.
• Job grade: AD 8.
• Location: Amsterdam, the Netherlands. Relocation to take up duties is mandatory.

Eligibility criteria - general conditions

• Full rights as a citizen of a European Union Member State, Iceland, Liechtenstein or Norway.
• Thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union (at least level B2).
• Fulfilled any obligations imposed by applicable laws concerning military service.

Eligibility criteria - specific conditions

• A university degree of at least four years in life science or general sciences (e.g. biology, chemistry, biochemistry, pharmacy, engineering) and at least 9 years' relevant professional experience after the degree; or
• A university degree of at least three years in the same fields and at least 10 years' relevant professional experience after the degree.

The degree and experience must be obtained by the closing date of this vacancy notice. You will be asked to provide documentary evidence at the interview stage.

Experience you need to have

• Out of the years of professional experience required above, at least 5 years relevant to manufacturing/GMP, e.g. in manufacturing of human or veterinary medicinal products, quality control, quality assurance, innovative manufacturing and/or GMP inspections/audits, in the pharmaceutical industry or a competent authority for medicines regulation.

Skills and knowledge you need to have

• Critical review and drafting of scientific and regulatory documents for expert and lay audiences.
• Proficient in the use of modern IT systems, with the ability to work with, analyse and draw conclusions from large sets of data.
• Knowledge and understanding of the EU pharmaceutical legislation and the regulatory framework for pharmaceutical products in the EU, including ICH guidelines relevant to the role.
• Presenting scientific or regulatory matters at a high level (e.g. to experts).

Competencies you need to have

• Role competencies (advanced): influencing and persuading; prioritising and organising. (Intermediate): scientific evidence management; scientific product lifecycle and procedure management.
• Sub-family competencies (advanced): regulatory frameworks and strategy; applied knowledge management.
• Grade competencies (advanced): coping with pressures and setbacks; analysing and problem-solving. (Intermediate): adaptability and agility.
• Core competencies (advanced): team collaboration; customer centricity; results orientation; communication; cross-cultural sensitivity. (Intermediate): ethics and integrity; continuous learning and self-development.

Nice to have

• Master's degree in regulatory science, regulatory affairs, quality, manufacturing, pharmaceutical technology, or quality business leadership.

• Background and/or work experience in novel/innovative manufacturing technologies or products (e.g. ATMPs, bedside manufacturing, continuous manufacturing); the use of artificial intelligence and/or automation in pharmaceutical manufacturing; or regulatory affairs, with a clear understanding of how GMP interacts with marketing authorisation applications.

• Meaningful work contributing to protecting the health of every individual and animal in Europe within multinational, multidisciplinary team

• Development opportunities (e.g. internal mobility, mentoring, peer coaching, career reflection programme, etc.)

• Work-life balance (flexible working arrangements, teleworking, generous annual leave plus official holidays)

Benefits

• In principle, initial 5 year renewable contract with competitive monthly national tax-free salary and household & children's allowances (where applicable). Contracts of a shorter duration may be offered.
• Privileges including expatriation (for expatriate staff) and education allowances (where appropriate) and additional home leave.
• Relocation assistance.
• Excellent health insurance scheme and social benefits.
• Retirement Pension Plan.

Monthly net salary of 8.911,48 Euro, including local weighting, plus benefits, based on a full-time contract of 40 hours per week.

The local weighting adjusts salaries to the cost of living in the Netherlands compared to Brussels. The current weighting for the EMA's location in Amsterdam, the Netherlands, is 113.2. Please consult the Eurostat and Commission websites for more information on weightings, and the salary and benefit calculators on the EMA careers website.

The aim of this selection procedure is to create a reserve list of qualified and suitable candidates. Candidates who reach the final step will be notified by e-mail whether they have been placed on the reserve list and the relevant Talent Pool. Placement on a reserve list and/or Talent Pool does not guarantee an employment offer.

Salary: 105000 – 110000 EUR / YEAR

Direct solliciteren

solliciteer op website van werkgever

Advertentie Cv voorbeelden voor Onderwijs, Onderzoek & Wetenschap: zo ziet een sterk cv eruit Bekijk het voorbeeld en maak je eigen versie. Bekijk voorbeeld Geen account nodig