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.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job