Senior Manager, QA

Genmab

Copenhagen, Denmark

The Role & Department

Genmab seeks a skilled GMP Quality Assurance (QA) Senior Manager to support commercial activity within QA. You'll ensure compliance with regulations, industry standards, and Genmab’s Pharmaceutical Quality System. You will play a key role in overseeing commercial manufacturing activities.

The Genmab QA GMP team comprises 32 members across Denmark and the US. This role reports to the Director of QA GMP Commercial & Lifecycle, based in Denmark. This role is based in Copenhagen, Denmark, and is hybrid.

Key Responsibilities Include

Quality Oversight of Contract Manufacturing Organizations (CMOs) in relation to GMP activities including Audits, Vendor Risk Evaluations and Quality Agreements.
QA responsible for quality decisions in relation to batch manufacturing of Biological Intermediates (BI), Chemical Intermediates (CI) and Drug Substances (DS), in collaboration with CMOs.
Batch Review and QP Release of BI, CI and DS.
Gaining and maintaining knowledge on new/updated GMP-regulations and guidelines.
Maintaining and continuously improving Genmab’s Pharmaceutical Quality System to ensure compliance with relevant regulations.
Reviewing, authoring and approval of QMS SOPs, Work Instructions and other documents, as needed.
Handling of Deviations, CAPAs and Change Control in compliance with Genmab SOPs and applicable regulatory requirements.
QA representative for transfer of product from QA Late Stage to QA Commercial & Lifecycle.
Represent GMP QA in project teams to advise on GMP compliance and execute QA activities.
Provide/facilitate GMP training.

Requirements

Master’s degree in a life sciences field or equivalent – must have the qualification to act as a delegated QP.
8+ years of QA experience in the biotech or pharmaceutical industry, with a focus on biological intermediate, chemical intermediate and drug substance is preferred.
Experience in QA manufacturing support in relation to commercial activities.
QP (delegate) experience is highly desirable.
Experience in outsourcing management, audit execution, and global stakeholder collaboration are advantages.
Comprehensive understanding of GMP guidelines and relevant regulations.
Demonstrated ability to work in a fast-paced, dynamic environment.
Exceptional communication skills in English with a collaborative, solution-oriented approach.
Strong organizational skills with a commitment to meeting goals and delivering high-quality outcomes.
Ability to foster a culture of quality and continuous improvement within cross-functional teams and continuous improvement within cross-functional teams.

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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