View all openings

Director, QA GMP & Leader, Commercial & Lifecycle

Nordics, Europe
A scientific leader in their field, our client is at the forefront of developing a robust portfolio of investigational medicines with the potential to improve the lives of patients.

Our client is a Nordic-based, international biotechnology company specializing in the creation and development of differentiated therapeutics for the treatment of certain immunological diseases based on proprietary technologies.
For decades, our client has delivered next-generation technology platforms while leveraging translational research and data sciences, fueling multiple differentiated immunological treatments that make an impact on people’s lives.
With a clear strategy of becoming an integrated end-to-end biotech innovation powerhouse, our client recently started to market and sell their own products within cancer treatment. Expanding its focus to also being directly vested in the commercialization of the company’s products, our client is now looking to further strengthen the Commercial & Life Cycle area within QA – and its leadership. Reporting to the Senior Director, QA GMP the role of Director, QA GMP & er - Commercial & Life Cycle will take a seat on the QA GMP leadership board while leading a team of 5-10 FTEs and Subject Matter Experts in Denmark and the United States (team expected to grow further).

The position is responsible for planning and executing QA related activities within GMP/GDP and our client’s Pharmaceutical Quality System, and the Director will take on a leading role in ensuring commercial and affiliate GMP/GDP processes are in place and compliance achieved while also acting as a consultant on GMP and GDP issues. Moreover, the role must direct the effort ensuring that Quality Audits within the GMP/GDP regulated areas are conducted, contractors/vendors are approved, in cooperation with the departments/affiliates, and that quality agreements are reviewed and approved.

The position as Director, QA GMP & Leader - Commercial & Life Cycle at our client offers an exciting and challenging position in an informal – though highly professional, 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 GMP QA Commercial & Life Cycle team. Hence, the role requires strong leadership capabilities of building and coaching a team of highly skilled specialists to successfully delivery on targets.

As Director, QA GMP & Leader - Commercial & Life Cycle at our client:
  • You will have huge impact on further strengthening the compliance platform of the company.
  • You will take a seat on the GMP QA leadership team where you can impact the strategic quality direction of the area.
  • You will lead a team of highly qualified and well-functioning specialists in a company with a unique impact on therapeutics for the treatment of cancer.
  • You will work in a highly successful biotech company, less influenced by big corporate bureaucracy and with a rather flat organization with few layers.
  • You will join a successful company with strong current and projected growth and record high investments in product innovation.
Position title:
Director, QA GMP & Leader - Commercial & Life Cycle.
Reporting line: Senior Director, QA GMP.
Reporting to the position: 5-10 FTE’s.
Location: Northern Europe.
Traveling: Ability to travel up to 20%.
Responsibilities & Tasks:
  • Leading, developing, motivating and engaging the QA GMP Commercial & Life Cycle team.
  • Representing QA in CMC project groups and in collaborations with external companies.
  • Gaining and maintaining expert knowledge on new GMP/GDP-legislation, guidelines and practices - including ensuring that the information is distributed to relevant parts of the Our client organization including affiliates.
  • Participating in developing, maintaining and improving the Pharmaceutical Quality System (PQS) with particular focus on commercial and affiliate GMP/GDP processes and compliance.
  • Assessing, authoring and approving PQS Policies and SOPs, including participation in relevant PEGs.
  • Ensuring integration of affiliates in PQS and providing oversight of and support to affiliate organizations.
  • Defining, implementing and leading a commercial/affiliate branch within QA GMP in collaboration with Head of GMP QA.
  • Handling Deviations, CAPAs and Change Requests in compliance with our client’s SOPs and applicable regulatory requirements.
  • Approving Major Change Control Quality Events delegated from Head of GMP QA.
  • Approving contractors/vendors in cooperation with the departments/affiliates, outsourcing the work and ensuring that relevant agreements/contracts are in place.
  • Participating as needed in inspections performed by national authorities.
  • Conducting Quality Audits within the GMP/GDP regulated areas internally and externally – according to procedures and plans.
  • Reviewing and approving Quality Agreements with contractors, partners and internal quality departments as relevant for commercial and lifecycle activities. 
  • Approving annual Vendor Risk Evaluations and Product Quality Reviews as relevant for commercial and lifecycle activities.
  • Handling complaint investigations and product recalls in close collaboration with external vendor(s).
  • Proactively contributing to Quality topics in the department and in the GMP QA team and driving to finalization.
  • Ensuring appropriate training of our client employees in Quality topics as assigned by QA /GMP QA.
  • As delegated Qualified Person (QP)
    • Assessing and approving/rejecting documentation.
    • Batch release of intermediates, Drug substance, Drug Product and batch certification of Investigational Medicinal Product (IMPs) and authorized products including release, quarantine and rejection.
  • Batch Certification of unlicensed medicinal products for pre-authorization access, compassionate use, Named Patient Programs, including release, quarantine and rejection.
Key success criteria:
  • Building improved QA GMP Commercial & Life Cycle muscle in the organization.
  • Contributing to the continued successful delivery of commercial products to the market.
  • 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.
  • Contributing to the enhancement of cross-functional collaboration within our client.
  • Creation of a high-performing culture in the department of QA GMP Commercial & Life Cycle – hereunder strengthening site internal and cross-border collaboration.
  • Building and sustaining excellent relationships at multiple levels throughout the organization and external stakeholder landscape - hereunder e.g. ensuring successful collaboration with external commercial partners.
Educational background: Minimum M.Sc. – Engineering or Scientific discipline (preferably also appropriate education required for delegate QP responsibilities).
Language: English – fluent (verbally and written).
Ideal experience:
  • +6 years of experience preferably with biologics’ within the biotech/pharmaceutical/CRO industries, and in a Quality Assurance function.
  • Broad experience within GMP and GDP.
  • Preferably proven leadership skills with a track record of building effective and coherent teams.
  • Demonstrated knowledge in the regulatory areas of importance to (e.g., FDA/EU Regulations, 21 CFR Part 11, ICH-GCP, HIPAA/data privacy and preferably also PMDA (Japan)).
  • Experienced in quality metrics creation, reporting and analysis as well as process improvement techniques.
  • Preferably both internal and external audit experience.
  • Well-versed with working in an environment with changing priorities.
  • Well-versed in setting the direction for a department/strategy and delegation and prioritization of tasks.
Personal & leadership competencies: Judgment
Makes rational, realistic and sound decisions based on the involvement of available facts and possibilities. Is able to make the right decisions.

Cross-cultural leadership
Performs superior leadership in global and dynamic contexts, with strong focus towards relationship building and management, alongside the attraction, recruitment and development of human capabilities 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
Collaborates and works well with others with a view to obtain overall team objectives. Is involving and supporting of team members and shares information.

Possesses professional curiosity and a pragmatic approach to finding solutions while engaging with specialists, and technicians.

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

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 within the corporate value-chain etc. Achieves agreement by dealing with disagreements and potential conflicts with diplomatic skills and develops and maintains networks.

Possesses the ability to identify the most important and prioritized issues at first and act on them. Assesses the importance of considerations, decisions and actions, and analyses most important issues first.

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.

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.

Other job opportunities

Senior Director, Biometrics
Senior Manager
Senior Partner

Share this opportunity

Powered by