Senior Scientific Specialist (GMP)

EUROPEAN MEDICINES AGENCY; Amsterdam; Vor Ort; EUR 97.000 - 117.000; Vollzeit

Benefits dieser Stelle

Relocation assistance

Excellent health insurance

Education allowances

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Jobbeschreibung

Select how often (in days) to receive an alert:

Internal job grade and Interagency: AD06 and above

Type of position: Temporary agent

Selection procedure reference: EMA/AD/11636

Job title: Senior Scientific Specialist (GMP)

Talent Pool: AD08 Science & Regulation

Salary: 9577,39 Euro (including local weighting) [1] plus benefits (see calculators on the right) (based on a fulltime contract (40hrs/week))

Location: Amsterdam, Netherlands (relocation to take up duties is mandatory)

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Role summary

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

The role involves contributing 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. The role also involves supporting the Good Manufacturing and Distribution Practice (GMDP) Inspectors’ Working Group (IWG), representing inspection topics internally and externally and international collaboration.

We are seeking a motivated professional with strong GMP expertise, a broad understanding of the product lifecycle, and the ability to balance technical knowledge with strategic thinking. The ideal candidate will have strong communication and organisation skills, the ability to work both autonomously and in a team, can drive topics forward, ensuring the views of stakeholders are heard, while also contributing their own expertise.

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

In this role 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 of pre-approval and post-approval GMP and Plasma Master File (PMF) inspections
• Coordinate of 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/coordinate to 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, 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.

Here is the link to the Role Description of Senior Scientific Specialist outlining generic duties and responsibilities:

Apply if you meet these eligibility criteria:

To be eligible for consideration for this position, you are required to meet the following general and specific eligibility conditions:

General conditions:
1.enjoy full rights as a citizen of a European Union Member State, Iceland, Liechtenstein or Norway;
2.have a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union (at least level B2);
3.have fulfilled any obligations imposed by applicable laws concerning military service.

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Specific conditions:

1.possess a university degree (minimum of four years) in the field of Life Science or General Sciences (e.g. biology, chemistry, biochemistry, pharmacy, engineering) that must have been obtained by the closing date of this vacancy notice, and at least 9 years’ relevant professional experience after obtaining the relevant degree, that must have been obtained by the closing date, in the field of the above-mentioned areas and duties.

or

2. possess a university degree ( minimum of three years) in the field of Life Science or General Sciences (e.g. biology, chemistry, biochemistry, pharmacy, engineering) that must have been obtained by the closing date of this vacancy notice, and at least 10 years’ relevant professional experience after obtaining the relevant degree, that must have been obtained by the closing date, in the field of the above-mentioned areas and duties.

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General Condition 1 and Specific Conditions 1 and 2will be verified firstly based on the application form and then you will be required to provide documentary evidence at the interview stage. Failing to present these documents may result in the disqualification from the selection procedure.

Only eligible candidates will be assessed by the Selection Committee.

You will also need to have:

Experience

Out of the years of professional experience required above, at least 5 years of experience of relevance to manufacturing/GMP. This experience could be gained from work in the areas of manufacturing of medicinal products for human or veterinary use, quality control, quality assurance, innovative manufacturing and/or GMP inspections/audits, in either pharmaceutical industry or competent authority in the field of medicines regulation.

Skills & Knowledge

• Critical review and drafting of scientific and regulatory documents for expert and lay audiences;
• Proficient in the use of modern IT systems, and has 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 (eg to experts).

Competencies you will need to have:

Influencing and persuading - Advanced

Prioritising and organising — Advanced

Scientific evidence management - Intermediate

Scientific product lifecycle and procedure management - Intermediate

Sub-family competencies

Regulatory frameworks and strategy — Advanced
Applied knowledge — Advanced

Grade competencies
Adaptability and agility — Intermediate
Coping with pressures and setbacks — Advanced
Analysing and problem-solving — Advanced

Core competencies
Ethics and integrity — Intermediate
Team collaboration — Advanced
Customer centricity — Advanced
Results orientation — Advanced
Communication — Advanced
Cross-cultural sensitivity — Advanced
Continuous learning and self-development — Intermediate

The assessment of competencies forms an important part of this selection process. EMA therefore advises you to refer to its Competency Framework for more information on the definitions of these competencies and their associated levels.

These are considered Nice to have:

Education

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

Experience

Background and/or work experience in the following areas:

• Novel/innovative manufacturing technologies or products (e.g., ATMPs, bedside manufacturing, continuous manufacturing); and/or
• Use of artificial intelligence and/or automation in pharmaceutical manufacturing activities
• Regulatory affairs (which allows for a clear understanding of GMP and how it interacts with submissions of marketing authorisation application

Selection procedure timelines - Please note, timelines may change

Deadline for applications

Foreseen: 22 November 2026 at 23:59 CET

Preliminary Assessments

Foreseen: Week of 11 January 2027

Final assessments

Foreseen: Week of 25 January 2027

Foreseen: Second week of February 2027

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Selection process

Only eligible candidates (see eligibility criteria) will be assessed by the selection committee.

Suitability and qualifications of eligible candidates will be assessed against the assessment criteria and competencesin different steps of the selection procedure.

Note: Candidates who fail any assessment linked to any Need to Have requirement, Sub-family competencies, Role competencies, Grade specific competencies, and Core Competencies at any stage of the process are disqualified, despite getting points on other criteria.

Before the start of the selection procedure, it is decided which criteria and competences will be assessed at each stage of the process. Certain criteria / competences will be assessed / scored only for shortlisted candidates during interviews (and/or tests). Please consult the Careers at EMA - Guidance on selection and recruitment (section 1.3. selection procedure) for an overview of the criteria and competences assessed at each stage of the process.

Shortlisting

In order to allow the selection committee to carry out an objective assessment of all candidates in a structured way, as part of their application, all candidates must answer the pre-defined set of questions based on Need to have criteria, Sub-family competences and Role competencies.

The Selection Committee will therefore assess eligible candidates using the information provided in the responses to those questions and in their application. When answering a question, you should include all relevant information, even if it is already mentioned in other sections of your application form.

Next steps of selection may include preliminary assessments. Most assessments will be conducted remotely (i.e. Webex/Teams, remote test, etc.). All assessments are based on the assessment criteria listed in this vacancy notice.

Shortlisted candidates will participate in personality assessments (e.g. SHL occupational personality questionnaire OPQ32) to assess their Core Competencies (pass score is 26 out of 100 points and above). In addition, selected Core Competencies may be assessed throughout the process.

Additional assessments, such as cognitive (e.g. deductive reasoning)assessments might also be foreseen as part of the selection process. Furthermore, motivation and overall fit for the job and knowledge of EU relevant to role may be assessed.

The aim of this selection procedure is to create a reserve list of qualified and suitable candidates. Each candidate having reached the final step of the selection procedure will be notified via e-mail whether she/he has been placed on the reserve list, and relevant Talent Pool. Candidates should note that the placement on a reserve list and/or Talent Pool does not guarantee an employment offer.

We strongly encourage that candidates do not apply for the vacancies that are at the same grade and the same subfamily as the Talent Pool they have been placed on, as this will not improve their chances of being considered for a vacant post within the Agency.

When a vacancy becomes available, candidates on the reserve list may be contacted for an additional interview.

More information about selection and recruitment (including administrative complaint procedure) at the EMA is available at our careers website .

Conditions of employment

In principle, the Agency offers a five-year renewable contract. Contracts of a shorter duration may be offered to the candidates.

The successful candidate will be required to relocate to the Netherlands to pick up duties.

[1] The local weighting adjusts salaries to the cost of living in the Netherlands compared to Brussels. The current weighting for the EMA's location inAmsterdam, the Netherlands , is 113.2. Please consult the Eurostat and Commission websites for more information on weightings.

Domenico Scarlattilaan 6 - 1083HS Amsterdam - The Netherlands

Join us to work for every patient in Europe!

Who we are?

Serving a population of 500 million citizens, we promote and protect public 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.

What do we offer?

• Meaningful work contributing toprotecting the health of every individual and animal in Europewithin 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)

(applicable only to Temporary Agentand Contract Agent vacancies)

• In principle, initial 5 year renewable contract with competitive monthly nationaltax-free salaryand household & children’s allowances (where applicable).
• Privileges including expatriation (for expatriate staff) and education allowances (where appropriate) and additional home leave.
• Relocation assistance.
• Excellent health insurance scheme and social benefits.

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