Senior Scientific Specialist (GMP)

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:

https://www.ema.europa.eu/en/documents/recruitment/role-description-scientific-senior-specialist-ad8_en.pdf

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 2 will 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:

Role competencies

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