Senior Manager QA Commercial & Life Cycle – CI, BI & DS (Maternity Cover)
Share
Job Location:
Copenhagen - Denmark
Monthly Salary:
Not Disclosed
Posted on:
19 hours ago
Vacancies:
1 Vacancy
Job Summary
At Genmab we are dedicated to building extranotordinary futures together by developing antibody products and groundbreaking knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create champion and maintain a global workplace where individuals unique contributions are valued and drive innovative solutions to meet the needs of our patients care partners families and employees.
Our people are compassionate candid and purposeful and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes our work is incredibly serious and impactful but we have big ambitions bring a ton of care to pursuing them and have a lot of fun while doing so.
Does this inspire you and feel like a fit Then we would love to have you join us!
The role
As part of Genmabs strategy to strengthen end-to-end quality oversight across the supply chain we are seeking a Senior Manager QA CI BI & DS to ensure continued strong GMP quality oversight during a period of parental leave with an expected duration until ultimo January 2027.
The role is based in Denmark and reports to the Director responsible for QA Commercial. You will be part of an experienced and highly skilled QA team responsible for quality oversight of Chemical Intermediates (CI) Biologic Intermediates (BI) and Drug Substance (DS) working closely with CMOs partners and internal SMEs.
Key Responsibilities
- Provide GMP QA oversight of CI BI and DS manufacturing activities at external CMOs
- Review and approve deviations CAPAs change controls and investigations in accordance with Genmab SOPs and regulatory requirements
- Support batch disposition activities and ensure appropriate quality decisions for CI BI and DS including QA review
- Contribute to Product Quality Reviews (PQR/APR) for CI BI and DS
- Review author and maintain QMS documentation including SOPs work instructions and templates
- Act as QA representative in cross-functional project teams and advise on GMP compliance and regulatory expectations
- Maintain strong collaboration with internal stakeholders partners and CMOs to ensure robust and compliant supply chains
Requirements
Bachelors or Masters degree in a relevant life science discipline
Minimum 5 years experience in the pharmaceutical industry preferably within QA GMP
Experience with CI BI and DS GMP production and delegated QP responsibilities
Excellent communication and collaboration skills; fluent in English
Ability to thrive in a fast-paced and changing environment
Results-oriented and committed to contributing to Genmabs overall success
About You
You are genuinely passionate about our purpose
You bring precision and excellence to all that you do
You believe in our rooted-in-science approach to problem-solving
You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
You take pride in enabling the best work of others on the team
You can 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!
Locations
Genmab maximizes the efficiency of an agile working environment when possible for the betterment of employee work-life balance. Our offices are crafted as open community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether youre in one of our office spaces or working remotely we thrive on connecting with each other to innovate.
About Genmab
Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years its hard-working innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational quantitative and data sciences resulting in a proprietary pipeline including bispecific T-cell engagers antibody-drug conjugates next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030 Genmabs vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.
Established in 1999 Genmab is headquartered in Copenhagen Denmark with international presence across North America Europe and Asia Pacific. For more information please visit and follow us on LinkedIn and X.
Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice ().
Required Experience:
Senior Manager
Key Skills
- Forecasting
- Hyperion
- Cost Management
- Construction Estimating
- QlikView
- Bus Driving
- Analysis Skills
- HubSpot
- Salesforce
- Market Research
- negotiation
- Financial Planning
About Company
Founded in 1999, we are an international biotech company committed to improving the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, our passionate, innovative and collaborative team has invented next-generation antibody technology platforms ... View more
