Senior Manager, Quality Assurance Regulatory
3 weeks ago
About the Role
We're looking for a highly motivated QA Senior Manager to join our team at Genmab, an international biotechnology company dedicated to improving the lives of patients through innovative antibody therapeutics. As a QA Senior Manager, you will play a key role in ensuring the quality and compliance of our clinical trials and regulated areas.
Key Responsibilities
- Plan, conduct, report, and follow up on quality audits within the GCP regulated areas.
- Mentor on-boarding QA colleagues as well as experienced Lead auditors to increase the competency level across the global QA GCP & PV team.
- Develop and maintain the audit strategies in collaboration with the Team Lead.
- Coordinate and lead GCP inspection readiness activities for FDA, EMA, and PMDA inspections.
- Participate in inspections and audits performed by our partners.
- Participate in, or drive the development, maintenance, and improvement of the Genmab QMS with focus on GCP and GCLP requirements.
- Conduct and coordinate internal GCP training.
- Deliver GCP advisory expertise both within the company and to external vendors.
Requirements
- MSc in Natural Science or similar and at least 5 years of profound experience within GCP and GCLP.
- Experienced Lead Auditor within GCP and/or GCLP, preferably with in-depth knowledge related to internal process audits and CRO audits of clinical data processing in different IT systems.
- Practical proficiency in the use and understanding of Veeva Vault QMS.
- Experience with the due diligence process and qualification of new vendors or services.
- Considered to be a Domain Expert within GCP and/or GCLP by peers with a strong interest and ability to educate others.
About Genmab
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. We believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.
Our vision by 2030 is that Genmab's antibody medicines will transform the lives of people with cancer and other serious diseases. We're committed to fostering workplace diversity at all levels of the company and believe it is essential for our continued success.
Genmab is committed to protecting your personal data and privacy. We have formed 20+ strategic partnerships with biotechnology and pharmaceutical companies to help develop and deliver novel antibody therapies to patients.
This role can be located in Copenhagen, Denmark, or Utrecht, the Netherlands, or Princeton, New Jersey, U.S. The role is hybrid, with an expectation of 60% on-site presence, combined with the option to work remotely two days per week on average.
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