Associate Director, QA GMP

Associate Director, QA GMP

Genmab

Copenhagen, Denmark

The Role & Department

At Genmab we are now looking to further strengthen the Late Stage Development QA Team located in Denmark. In this position, the Quality Assurance (QA) Associate Director will set the quality direction for Genmab’s Late Stage Development products.

As GMP QA Associate Director you will be an important part of the global GMP QA team to ensure compliance to industry standards and regulations. This position will be located in DK, reporting to the Director of QA GMP Late-Stage Development (temporarily located in the US). The role has no direct reports. The Global QA Department is composed of more than 50 employees working in GxP and are based in Denmark, the Netherlands, the US and Japan.

Key responsibilities include

  • Act as QA responsible for Manufacturing, Process Transfer, Process Validation for Antibody Intermediates, Chemical Intermediate, and Drug Substance ADC;
  • Act as QP delegate by releasing Antibody Intermediates, Chemical Intermediates and Drug Substance ADC for further manufacturing;
  • Providing QA oversight of CMOs in relation to outsourced GMP activities including Audits, Vendor Risk Evaluations, review and negotiation of Quality Agreements.

Additionally, perform the following tasks as a part of the GMP QA Team:

  • Contributing to Quality Oversight of CMOs by auditing GMP CMOs, negotiating Quality Agreements, and performing vendor evaluations;
  • Maintain training programs for GMP, train stakeholders in relevant GMP topics;
  • Maintaining and continuously improving Genmab’s Pharmaceutical Quality System (PQS) to ensure compliance with GMP regulations;
  • Reviewing and authoring of PQS SOPs, Work Instructions and documents;
  • Gaining and maintaining knowledge on new/updated GMP regulations and guidelines;
  • Representing QA GMP in project groups to advise on GMP compliance;
  • Promote collaborative relations with relevant internal stakeholders, partners, and CMOs;
  • Handling of Deviations, CAPAs and Change Control in compliance with Genmab SOPs and applicable regulatory requirements;
  • Participating in internal audits and audits and regulatory inspections performed by Partners, Health Authorities.

Skills & Experience

  • You hold a MSc degree or equivalent in a relevant life science subject;
  • You have +10 years of experience from the pharmaceutical industry within QA, preferably within biologics and/or chemical intermediate, and/or sterile products;
  • Experience within development products for clinical trials in late development phase including process validation is an advantage;
  • Outsourcing experience and lead auditor experience is an advantage;
  • Experience working in an EDMS system;
  • You have excellent communication skills in English, and a collaborative mindset;
  • As a person you enjoy an ambitious and changing environment;
  • You are result- and goal-oriented and committed to contributing to the overall success of Genmab.

About You

  • You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment;
  • You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving;
  • You are a generous collaborator who can work in teams with diverse backgrounds;
  • You are determined to do and be your best and take pride in enabling the best work of others on the team;
  • You are not afraid to grapple with the unknown and be innovative;
  • You have experience working in a fast-growing, dynamic company (or a strong desire to);
  • You work hard and are not afraid to have a little fun while you do so.

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