Head of Inspections Office, Human Medicines Division
European Medicines Agency
Hospital, Public and Private
Health Care System
Internal Number: VONQ-00052690
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.
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.
To be eligible for consideration for this position, you are required to meet the following general and specific eligibility 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.
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.
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.
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.
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.
Translating strategies (Intermediate ) - Ability to set and revise objectives for one's area of responsibilities within the overall strategic framework and priorities.
Organizing and managing operations (Intermediate) - Ability to organize 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.