GMP QA Senior Manager – Process Validation
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Job Location:
Copenhagen - Denmark
Monthly Salary:
Not Disclosed
Posted on:
11 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
Genmab is looking for an experienced GMP QA Senior Manager to join our QA Process Validation this role you will play a key part in setting and maintaining quality standards for Process Performance Qualification (PPQ) and process transfers across both commercial and development products.
This is a senior individual contributor role with no line or people management responsibilities offering the opportunity to work hands-on with complex global projects.
You will become part of Genmabs global GMP QA organization with colleagues across Denmark the Netherlands the US Japan and China. The position is based in Denmark and reports to the Director of QA GMP Process Validation.
Responsibilities
As GMP QA Senior Manager your responsibilities will include:
Acting as QA for PPQ and process transfer activities
Performing batch review of intermediates drug substance and drug product
Collaborating closely with internal stakeholders and Contract Manufacturing Organizations (CMOs)
QA oversight of CMOs and leading CMO audits
Representing GMP QA in global project teams
Authoring SOPs and managing deviations CAPAs and change controls
Ensuring ongoing inspection readiness and regulatory compliance
Providing and facilitating GMP training
Contributing quality input to the continuous improvement of Genmabs Pharmaceutical Quality System
Requirements
To succeed in this role you should have:
A Masters degree in life sciences or an equivalent qualification
At least 5 years of QA experience within the biotech or pharmaceutical industry
Experience with chemical intermediates is an advance
Hands-on experience with PPQ process validation manufacturing support and process transfers for late-stage or commercial products
Strong knowledge of GMP guidelines and regulatory requirements
Experience with outsourcing audits and global stakeholder collaboration
Excellent communication skills in English with a collaborative and solution-oriented mindset
Strong organizational skills and the ability to thrive in a fast-paced environment
A proactive results-driven approach and a strong commitment to quality and continuous improvement
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.
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Required Experience:
Senior Manager
Key Skills
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
