Dynamic QA Leader for Biotech Innovation
14 hours ago
At Genmab, we strive to push the boundaries of what's possible in cancer treatment and serious diseases. Our pioneering spirit drives us to develop innovative therapies that change lives.
The Role & Department
As a GMP QA Manager, you will play a key role in our well-functioning QA Commercial & Life Cycle team, responsible for quality oversight of starting materials, intermediates, and drug substances for commercial products.
You will collaborate closely with our Contract Manufacturing Organizations (CMOs)/Partners and process- and QC SMEs internally at Genmab.
This position is located in DK, reporting to the Director of QA GMP Commercial & Life Cycle (located in DK). The Global QA Department has 50+ employees supporting GxP activities and located in Denmark, the US, and Japan.
Responsibilities & Tasks
- Maintain and continuously improve Genmab's Pharmaceutical Quality System to ensure compliance with EU and US regulations.
- Gain and maintain knowledge on new/updated GMP/GDP-regulations and guidelines.
- Handle 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).
- Review and author QMS SOPs, Work Instructions, and other documents as needed.
- Support Quality Management Review and Annual Product Review.
- Perform QA activities related to US market release in close cooperation with the global QA GMP team, Genmab's CMOs, contract acceptors, and Partners.
- Provide QA oversight of contractors/vendors in relation to outsourced GMP/GDP activities, including audits, vendor risk evaluations, and review/negotiation of Quality Agreements.
- Represent QA GMP in project groups to advise on GMP compliance.
- Participate 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
- Hold a Master's degree or equivalent in a relevant life science subject.
- Have 5+ years of 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.
Additionally, you should have:
- Excellent interpersonal skills, problem-solving skills, communication skills in English, and a collaborative attitude.
- Enjoy working in a fast-paced and changing environment.
- Be results and goal-oriented, committed to contributing to the overall success of Genmab.
- Be pragmatic yet attention to necessary details.
- Clear and persistent in your communication, expectations, and requirements to quality.
About You
- Be passionate about our purpose and genuinely care about our mission to transform lives through innovative cancer treatment.
- Bring rigor and excellence to all that you do.
- Believe in our rooted-in-science approach to problem-solving.
- Be a generous collaborator who can work in teams with diverse backgrounds.
- Determine to do and be your best and take pride in enabling the best work of others on the team.
- Not afraid to grapple with the unknown and be innovative.
- Have experience working in a fast-growing, dynamic company (or a strong desire to).
- Work hard and not afraid to have a little fun while doing so.
Locations
Genmab leverages the effectiveness of an agile working environment for better employee work-life balance.
Our offices are designed as open, community-based spaces that connect employees while being immersed in state-of-the-art laboratories.
We thrive on connecting with each other to innovate.
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