Senior Scientific Specialist - Inspections

About this position:

The new pharmaceutical legislation will simplify structures and procedures which have been introduced by different pieces of legislation over the years. A simplified and more integrated regulatory system will be easier to navigate for developers and aims to make Europe more attractive and competitive in the global environment. 

The revised legislation will also reduce administrative burden, to help improve sustainability of the European medicines network, rationalise the use of the scientific assessment resources in the network, and become more agile in dealing with complex medicine assessments. 

In this context, EMA is looking for a Senior Scientific Specialist in the Inspections Office, Quality and Safety Department of EMA’s Human Medicines Division.  

This is a unique opportunity to be at the forefront of the set-up and operation of the EMA inspectorate, act as an ambassador for the EMA, and work with top experts from the EU and globally. 

The specialist is expected to act as an inspector either in the area of Good Manufacturing Practice (GMP) or Good Clinical Practice (GCP) for the proposed EMA inspectorate. The EMA inspectorate is expected to be implemented due to the reform of the Pharmaceutical Legislation, commonly known as the New Pharma Legislation (NPL). In this role the specialst will be supporting oversight of global pharmaceutical manufacturing via the inspection of manufacturing facilities or of clinical research and development via the inspection of sites involved in the conduct/management of clinical trials. In most cases these will be joint inspections with the national inspectorates of EU Member States.  

It is envisaged that vast majority of these inspections will take place in third countries (outside of the EU), and thus this role requires extensive travel, including the potential to be located overseas, therefore the specialist will be required to travel for extended periods of time to both EU and non-EU countries, including potentially being based in a non-EU country for a period of time.  

The specialist will also be involved in the set-up of the EMA inspectorate, including the development of a quality management system (QMS) and ensuring the inspectorate is ready for audit under the Joint Audit Programme (JAP). The aim of the inspectorate is to boost European inspection capacity, strengthening compliance oversight and the protection of patient safety.  

Other activities include being a representative for the EMA Inspectorate at external fora, such as conferences, representing the EMA inspectorate at the GMDP or GCP Inspector Working Group and supporting the drafting of guidelines.  

The specialist may also be asked to contribute to routine EMA Inspections Office work, such as the co-ordination of inspections, product support, management of quality defects and recalls, although, it is envisaged that this will be limited.  

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. 

X
Specific conditions:  
1.    possess a university degree (minimum of four years) in Life Science (e.g. pharmacy, biology, chemistry, biochemistry) or Medicine (human/veterinary) 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. 

Xor

2.   possess a university degree of three years in Life Science (e.g. pharmacy, biology, chemistry, biochemistry) or Medicine (human/veterinary) 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.  

X

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 candidates eligible will be assessed by the Selection Committee.

You will also need to have:

Experience

Experience requirements for either the GMP or the GCP profile must be met.

X

For GMP profile:

Be Qualified Person (QP) or QP eligible in accordance with requirements set out in Article 49 of Directive 2001/83/EC

AND at least 5 years of experience:

• as auditor with conducting audits of pharmaceutical finished product manufacturers or suppliers, including of sterile facilities 

OR 

• as inspector with conducting inspections of pharmaceutical finished product manufacturers or suppliers, including inspections of sterile facilities  

X 

For GCP profile:

At least 5 years of experience in conducting: 

• audits of clinical trial investigator sites and sponsors/contract research organisations (CROs)

OR 

•  inspections of clinical trial investigator sites and sponsors/contract research organisations (CROs)

Skills & Knowledge 

• Strong communication, assertiveness and diplomacy skills, to allow for representation of the EMA at external fora and overseas ; ( assessed together with Communication - Core competency) 
• Strong organisational and planning skills, including the ability to manage oneself/be a self-starter; (assessed together with Prioritising an organising - Role comptency)
• Ability to handle fast paced and pressurised environments; (assessed together with Coping with pressure and set backs - Grade competency)
• The ability to understand and critical review of scientific and regulatory documents and the ability to explain/present key messages to expert and lay audiences;  (assessed together with Analysing and problem solving - Grade competency)
• 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; 
• Knowledge and understanding of current legislation and guidance in the area of expertise and ability to interpret those and advise on their application; 
• Knowledge of trends and innovative developments in the area of pharmaceutical manufacturing and/or clinical trials.

Competencies you will need to have:

Role competencies 

• Developing and applying innovative practices - Intermediate 
• Influencing and persuading – Advanced 
• Prioritising and organising – Advanced 
• Scientific evidence management – Intermediate
• Scientific product lifecycle and procedure management - Intermediate  

Sub-family competencies 

• Regulatory Framework 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 and or affairs, manufacturing technology or clinical research; 
• PhD and/or Specialization in a relevant field of study (Medicine or Life science disciplines). 

Experience (for GMP role)

• Experience with working with, auditing or inspecting advanced manufacturing technologies and novel products e.g. ATMPs ; 
• Experience of working with, auditing or inspecting advanced computerised systems (e.g. AI, cloud systems, etc).

Experience (for GCP role)

• Experience of supporting the conduct of, auditing or inspecting bioequivalence/bioanalytical studies; 
• Experience of working with, auditing or inspecting alternative trial types (e.g. decentralised trials) and novel technologies; 
• Experience of working with, auditing or inspecting advanced computerised systems (e.g. AI, cloud systems, etc).