BRIEF COMPANY PROFILE

THE POSITION

• 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 PROFILE

• 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.

• 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.

CANDIDATE PROFILE

• +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.