Manager, QA GMP
Genmab
Copenhagen, Denmark
As GMP QA Manager you will be a part of the well-functioning QA Commercial & Life Cycle team, with responsibility for quality oversight of starting materials, intermediates, and drug substances for commercial products. You will have a close collaboration with our Contract Manufacturing Organizations (CMOs)/Partners and process- and QC SMEs internally at Genmab.
Responsibilities & Task
- Maintaining and continuously improving Genmab’s Pharmaceutical Quality System to ensure compliance with EU and US regulations;
- Gaining and maintaining knowledge on new/updated GMP/GDP-regulations and guidelines;
- Handling of Deviations, CAPAs and Change Control in compliance with Genmab SOPs and applicable regulatory requirements;
- Act as Delegated QP for the release of commercial products (Biological Intermediates, Chemical Intermediates and Drug Substance);
- Reviewing and authoring of QMS SOPs, Work Instructions and other documents, as needed;
- Supporting Quality Management Review and Annual Product Review;
- Performing QA activities in relation to US market release in close cooperation with the global QA GMP team, Genmab’s CMOs, contract acceptors and Partners;
- Providing QA oversight of contractors/vendors in relation to outsourced GMP/GDP activities including Audits, Vendor Risk Evaluations, and review and negotiation of Quality Agreements;
- Representing QA GMP in project groups to advise on GMP compliance;
- Participating in internal audits and regulatory inspections performed by various Health Authorities;
- Train QA colleagues and stakeholders in relevant GMP topics;
- Promote collaborative relations with relevant internal stakeholders, partners and CMOs.
Requirements
- You hold a Master’s degree or equivalent in a relevant life science subject;
- You have 5+ years experience within the pharmaceutical industry within QA;
- Experience with biological and chemical GMP production;
- Experience with CMO collaboration;
- Experience with audits/inspections;
- QP/delegated QP experience.
Moreover it is expected that you have the following
- You have excellent interpersonal skills, problem-solving skills, communication skills in English, and a collaborative attitude;
- As a person you enjoy a fast-paced and changing environment;
- You are results and goal-oriented and committed to contributing to the overall success of Genmab;
- Pragmatic and yet with attention to the necessary details;
- Clear and persistent in your communication, expectations, and requirements to quality.
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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