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Head of Inspections Office, Human Medicines Division

Type of position:  Temporary agent
Shift Type:  23 September 2021, 23:59 CEST

Job grade: AD08 

Type of position: Temporary agent 

Selection procedure reference: EMA/AD/6348 

Job title: Head of Inspections Office, Human Medicines Division 

Deadline for applications: 23 September 2021, 23:59 CEST 

 

 

About this role

The Agency is looking to recruit a Head of Inspections Office. The role of the Inspection Office is to

  • Supervise compliance with Good Manufacturing and Distribution (GMDP), Clinical (GCP), Laboratory (GLP) and Vigilance (GVP) Practices for Human and Veterinary medicines throughout their lifecycle, including providing scientific support to the relevant Inspector Working Groups (GMDP, GCP, GLP and GVP);
  • Coordinate market surveillance activities ensuring quality of medicines;
  • Coordinate and support the network of regulatory agencies in the development and implementation of relevant legislation and guidelines related to good compliance practices;
  • Collaborate with EU and international partner authorities in the harmonisation of GxP standards, inspectional practices, and facilitate mutual reliance on inspectional outcomes;
  • Support capacity and capability building of inspectorates in the context of evolving standards and emerging technologies and embed inspections and compliance within continuous risk benefit assessment;
  • Contribute to initiatives in the EU relating to global supply chain issues and shortages

The Head of Office is accountable for the quality of outputs of the Office and the management of its scientific, technical and or/operational expertise and knowledge including to develop human resource plans and training programmes for staff. He/she will contribute to Department work, budget plans, and activity reports, and at large to the Agency’s strategy.

Job description

In this role and in the context of the Office’s mission and objectives, the Office Head will:
•    Provide scientific, technical and/or operational leadership in the domain of responsibility of the Office,
•    Foster collaboration and communicate across offices in the Division and the Agency,
•    Ensure team communication across the Agency vertically and horizontally,
•    Lead, coordinate and manage the team and individuals,
•    Ensure that the Office internal organisation is fit-for-purpose,
•    Ensure the team contributes to matrix activities as necessary (e.g. product teams, ad-hoc task forces etc.),
•    Set and monitor Office and individual objectives and performance indicators,
•    Direct, organise, plan and monitor activities of the team and individuals,
•    Coach, mentor and develop team members and manage their performance,
•    Negotiate the objectives and resources for the office,
•    Manage the office’s budget (as applicable),
•    Establish, monitor and report management information,
•    Analyse and propose solutions for the continuous improvement of quality and productivity,
•    Manage risks and the implementation and monitoring of quality assurance,
•    Manage external engagement of the Office and foster collaboration with EU and international partners.

 

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.

 

Specific conditions: 
1.    possess a university degree in pharmacy, medicines, biology, chemistry, life sciences, engineering or equivalent (minimum of four years) that must have been obtained by the closing date of this vacancy notice, and at least 9 years’ professional experience relevant to the studied degree, that must have been obtained by the closing date of this vacancy notice.
or
possess a university degree in pharmacy, medicines, biology, chemistry, life sciences, engineering or equivalent (minimum of three years) that must have been obtained by the closing date of this vacancy notice, and at least 10 years’ professional experience relevant to the studied degree after obtaining the relevant degree, that must have been obtained by the closing date of this vacancy notice.


For general condition 1 and for specific conditions 1 and 2 you will be required to provide proof in the application form and at the interview stage. Failing to present these documents may result in the disqualification from the selection procedure.
 

Essential Criteria

  • Proficient expertise and proven professional experience of minimum 5 years in in at least one of the following subject matter areas: the life-cycle management of medicines, regulatory affairs for medicines, GXP compliance, clinical trials or manufacturing and/or control of medicinal products, at the level required to assist, consult with or lead other professionals in the area of the Inspections Office (i.e. GMDP, GCP, GLP and GVP);
  • Proven experience of at least 2 years in managing small to medium sized teams.

Desirable criteria

 

  • Experience with multicultural environments or working in an international setting;
  • Experience in enabling innovation such as novel manufacturing approaches, novel methodologies used in clinical trials, in decentralised clinical trial; designs
  • Experience in medicines regulation or managing the lifecycle of medicines.

Behavioural competencies

  • Translating strategies (Intermediate ) - Ability to set and revise objectives for one's area of responsibilities within the overall strategic framework and priorities.
  • Organising and managing operations (Intermediate) - Ability to organise and manage the entity's work, to assign work among team members, to determine pertinent priorities, and to monitor and evaluate the progress made towards achieving the set objectives.
  • Guiding and building high performance teams (Intermediate)- Ability to ensure team members understand what is expected of them and how their work contributes to the team objectives; ability to build strong teams with complementary strengths suited to the efficient pursuit of the team’s objectives.
  • Motivating and developing staff (Intermediate)- Ability to motivate and empower team members to achieve the desired result; ability to support their development by providing regular feedback on their strengths and successes as well as learning opportunities in order for them to achieve their greatest potential
  • Communication and negotiation skills (Advanced) - Ability to communicate clearly, to present complex subjects simply, to solicit inputs from and listen to staff and stakeholders, and to effectively steer discussions in order to generate the best possible results.
  • Fostering cooperative relations (Advanced) - Ability to deal with people effectively, respectfully and courteously; ability to build productive and cooperative working relationships across the organization.
     

Selection procedure timelines

Deadline for applications

23 September 2021

Preliminary assessments (test)

Week of 11 October 2021

Final assessments (interviews and Assessment Centre)

Week of 25 October 2021

Decision expected

Week of 15 November 2021

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 in different steps of the selection procedure. Before the start of the selection procedure, the selection committee decides which assessment criteria will be used at each stage of the process. Certain criteria will be assessed / scored only for shortlisted candidates during interviews (and/or tests).


Shortlisting
In order to allow the selection committee to carry out an objective assessment of all candidates in a structured way, all candidates might have to answer the pre-defined set of questions as part of their application. 


The questions are based on the essential and desirable assessment criteria, as well as on behavioural competencies included in this vacancy notice. When answering a question, you should include all relevant information, even if it is already mentioned in other sections of your application form. The selection committee will assess whether you meet all the eligibility criteria, including your suitability for the position, using solely the information provided in the responses to those questions. 


To carry out this assessment, the selection committee may first assign each question a weighting that reflects its relative importance, and if so each of your responses will be awarded points (1 to 10). The points are multiplied by the weighting factor and added up to identify those candidates whose profiles best match the duties to be performed.


Only the candidates who meet the eligibility and essential criteria will through to the next stage.


Assessments
Next steps of selection may include a preliminary assessment (Skype, remote test, etc.) and / or an interview and a test in EMA premises. Please note that due to current travel restrictions the assessment may be conducted remotely. All assessments are based on the assessment criteria listed in this vacancy notice. 


At this stage, the selection committee will also look at the other sections of your application form (work experience, education, etc.). 
Candidates might participate in cognitive (e.g. deductive reasoning) and personality assessments (e.g. SHL occupational personality questionnaire OPQ32) as part of the selection process.


Reserve list and job offers
As a result of the assessments, the Selection Committee will recommend a list of most suitable candidates for the vacant position. Non-selected, but qualified and suitable candidates may be placed on a reserve list for future recruitments. This reserve list will normally be valid until the end of the next full calendar year (the validity period may be extended).


Each interviewed candidate will be notified in writing whether they have been placed on the reserve list. Candidates should note that the placement on the reserve list does not guarantee an offer of employment.
Candidates placed on the reserve list will also be evaluated by the Assessment Centre.

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.

The monthly basic salary, including the local weighting(1) which adjusts salaries to the cost of living in the Netherlands compared to Brussels, is €7,966.88. Note this salary is subject to deductions of community tax, health insurance and pension contribution. 

EMA offers a final salary pension scheme and a world-wide medical insurance.

In addition to the basic salary, the jobholder may be entitled to various additional allowances, including family allowances, such as education allowance for dependent children of school age, and expatriation allowance. Relocation and/or resettlement allowances may also be available upon entry into employment.

More detailed overview of various allowances and entitlements is available at our careers website.

Successful and selected internal and interagency candidates currently in grade AD06 or AD07, who do not fulfil the eligibility criterion with regards of years of experience required for the AD08 post (please see eligibility criteria), shall be offered to transfer to the EMA within the framework of internal mobility, and appointed in their current grade and step.

Please consult the Eurostat website for more information about the duty station weighting.

[1] The current weighting for the EMA's location in Amsterdam, the Netherlands, is 113.9. Please consult the Eurostat and Commission websites for more information on weightings.

 

______________________________________________________________________________________________________

If you currently hold a different contract, a contract in a different function group or your grade is outside the grade bracket stipulated in the vacancy announcement, you will receive a new contract. Chapter IV of the Rules on Temporary Agents 2f of the CEOS as of 1 July 2015 stipulate that the successful candidate will receive a new contract at the grade advertised and will serve probation.

If you currently hold a contract in a grade and function group corresponding to the grade bracket and function group coherent with the post to be filled, you will also be offered the opportunity to be assigned to the post by means of mobility under the provisions of Article 6(2) of the Rules on Temporary Agents 2f of the CEOS as of 1 July 2015.

If you are successful in the selection procedure and offered a position, you will be informed of the options available to you and asked to make a decision within a given timeframe (usually 10 working days).
 

 

Domenico Scarlattilaan 6 - 1083 HS Amsterdam - The Netherlands

Telephone +31 (0)88 781 6000 - Email recruitment@ema.europa.eu

 

© European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged.


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