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Director, QA

Copenhagen, Denmark
Our client develops and manufactures medical devices used in surgical procedures by health care professionals all over the world.  As an innovation and manufacturing house, our client provides full circle competences from identification and investigation of the initial user need, to concept and product development based on clinical insights, and finally to product registration, manufacturing, sterilization, and delivery to the market.
Reporting to the VP, QM&RA, the Director, QA will take a seat on the QM/RA leadership board while leading a team of 15 FTEs with a strong focus on ensuring compliance across the organization.  

The position as Director, QA at our client offers an exciting and challenging position in an informal – though dedicated and dynamic – organization with a high degree of interorganizational collaboration and focus on joint effort and commitment. The Director is expected to set a clear direction and provide situational leadership of the QA team. Hence, the role requires strong leadership capabilities of building and coaching a team of highly skilled QA specialists to successfully delivery to targets.

The ideal candidate must possess a strategic mindset and be a true team player with a focus on creating an open, inclusive, and collaborative work environment and establishing transparency in the team, possessing a solution-oriented mindset, and easing cross-functional collaboration and interactions between QA and other departments within our client’s organisation.

As Director, QA at our client:
  • You will have huge impact on further strengthening the compliance platform of the company.
  • You will take a seat on the QM&RA leadership team where you can impact the strategic direction of the organization.
  • You will lead a team of highly qualified and well-functioning QA-specialists in a company with a unique impact on global healthcare.
  • You will work in a medium sized company, less influenced by big corporate bureaucracy and with a rather flat organization with few layers.
  • You will work with Medical Device, Class III products.
  • You will work in a role that is highly regarded and valued in the company.
  • You will drive a QA department with a broad scope, leading the quality process from a-z.
  • You will join a successful company with a strong growth in the last few years and record high investments in product innovation and production capacity expansion.
Furthermore, the position will collaborate closely with our client’s long-standing commercialization- and innovation partner. In this context, the Director, QA will play an integral role in maintaining the strong and crucial relationship with our client's main commercial partner.

Consequently, the position calls for an experienced and skilled QA leader, ideally including strong proficiency in working in a medical device company. Additionally, a solution-oriented mindset, superior communication skills and strong stakeholder management capabilities are of the essence.
Position title:
Director, QA
Reporting line: Vice President, QM/RA
Reporting to the role: 15 specialists
Location: Greater Copenhagen
Traveling: Limited
Responsibilities & Tasks:
  • Leading, motivating and developing the QA department at our client.
  • Setting clear objectives for the QA team.
  • Securing a successful performance of the daily operation in the QA department, including overall responsibility for releases, complaints, QA review and approval of non-conformities, change requests, risk analyses, validations, qualifications, etc.
  • Continually optimizing and streamlining the QA area of Client to meet the demands of internal and external customers.
  • Ensuring that QA at our client is kept professionally and up to date in relation to applicable rules within relevant GMP/GDP/ISO legislation.
  • Leading the QA team/department to bring structure and facilitate cross-functional collaboration to ensure accountability and drive for results.
  • Ensuring continuous improvement and development of QA to ensure a high level of effectiveness and execution power in the team.
  • Managing time and resource planning for the team.
  • Contributing effectively to the maintenance of our client’s strong relationship with their key commercialization and innovation partner among others.
  • Keeping the quality system up-to-date and effectively functioning, including preparing, reviewing and approving controlled documents.
  • Participation in and follow-up on inspections from authorities and customers.
  • Informing upper management about efficiency and progress in QA's quality projects.
  • Ensuring that LEAN tools are incorporated into QA's daily task management.
  • Supporting the VP, QM & RA with Advisory Notices and recalls of products from the market.
  • Ensuring ongoing GMP training for the organization and support that awareness of applicable legal requirements and the requirements of the quality system is spread in the broader organization of our client.
  • Approving audit programs and ensuring the planning, execution and follow-up of internal and external audits.
Key success criteria:
  • Successfully building improved QA muscle in the organization, including clear strategy definition and implementation for the QA area.
  • Successfully delivering on QA-related KPI’s.
  • Exercising appropriate executive presence with the knowledge base and stature to deliver leadership in a manner that is respected and valued by the team and broader organization.
  • Inspiring and nudging the QA organization to become more outgoing/outreaching.
  • Contributing to a seamless collaboration with our client's key partner.
  • Contributing to the enhancement of cross-functional collaboration within the organization of our client.
  • Creation of a high-performing culture in the department of QA, including strong performance from each team member.
  • Building and sustaining excellent relationships at multiple levels throughout the organization and external stakeholder landscape.
Educational background: Minimum B.Sc. – ideally a degree at M.Sc. level.
Language: English – fluent (verbally and written).
Ideal experience:
  • Multiple years of experience with heading up a QA department from a highly regulated industry such as medical devices (prioritized), pharma, biotech, life science or similar.
  • Strong knowledge of quality systems, including but not limited to ISO, GxP, and FDA.
  • Highly experienced in stakeholder management.
  • Experience from a similar role managing and leading a department of highly skilled QA professionals.
  • Track record of creating superior project management delivery.
  • Experience in navigating within larger contexts and organizations preferred.
  • Demonstrated track record in finding pragmatic solutions to complex or challenging problems.
  • Well-versed with working in an environment with changing priorities daily.
  • Well-versed in setting the direction for a department/strategy and delegation and prioritization of tasks.
Personal & leadership competencies: Pragmatism
Possesses professional curiosity and a pragmatic approach to finding solutions while engaging with engineers, specialists and technicians.

Solution-oriented mindset
Looking past current problems to find solutions. Bringing a positive mindset to obstacles and having the ability to focus on the result, while solving or eliminating current challenges.

Stakeholder management and personal relations
Is able to establish and maintain relations with people at all levels and makes people feel at ease.  Able to work with other functions such as RA, Process Engineers, Supply Chain, Operations, Commercial and External Suppliers/CMOs etc. Achieves agreement by dealing with disagreements and potential conflicts with diplomatic skills and develops and maintains networks.

Inspiration and motivation
Inspires others and encourages the achievement of set goals by promoting a sense of purpose. Provides inspiration for a positive work attitude and prompts a strong wish to succeed in the team.

Possesses strong oral/written communication skills in English. Communicates the central issues in a discussion in a clear, fluent and precise manner and is able to keep the recipients' attention. Is attentive to the needs of others when speaking and produces written material which is easy to understand. Is able to successfully communicate with external business partners.

Team orientation
Capable of building strong organizations based on collaboration. Collaborates and works well with others with a view to obtain overall team objectives. Is involving and supporting of team members and shares information.

Visionary/strategic mind
Defines a clear vision and moves strategy to action. Looks beyond the immediate difficulties and focuses on the far-reaching consequences; sees things in a broad perspective; takes tendencies in the environment into account when planning and developing strategies.


Is undeterred and persistent despite resistance and difficulties, carries on when faced with adversity.

Structure and follow up
Works systematically, organizes work and effort and is methodical in one's performance. Possesses good overview. Plans actions to secure optimal use of time and resources, compares achieved results to set objectives and follows up on delegated tasks and decisions. Direct others toward successful execution of tasks, drives projects forward, follows through.

Results and goal orientation
Establishes visible and achievable goals for the department. Focus on action, activities and results. Is able to continue working at a specific problem, viewpoint or action plan until a result has been achieved or it is determined that an alternative approach is needed.

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