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Director of Quality Assurance, Regulatory Compliance
1 month ago
Genmab is seeking a highly motivated QA Senior Manager with at least 5 years of experience in GCP and/or GCLP to join our global team. As a key member of the quality assurance department, you will play a crucial role in ensuring compliance with regulatory requirements and maintaining the highest standards of quality.
The ideal candidate will have a deep understanding of GCP and GCLP regulations, as well as experience in conducting audits, developing audit strategies, and mentoring QA colleagues. You will also be responsible for coordinating inspection readiness activities, participating in inspections, and driving the development and maintenance of the Genmab QMS.
We are looking for a collaborative team player who can work effectively in a dynamic environment and communicate complex ideas clearly. The successful candidate will have a strong analytical mindset, excellent problem-solving skills, and the ability to adapt quickly to changing priorities.
In this role, you will have the opportunity to work on a wide range of projects, from auditing and training to process improvement and collaboration with cross-functional teams. Our offices are designed to foster a sense of community and innovation, with state-of-the-art laboratories and collaborative workspaces.
About the Role
- Plan, conduct, report, and follow up on quality audits within GCP regulated areas
- Mentor QA colleagues and lead auditors to increase competency levels across the global QA GCP & PV team
- Develop and maintain 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 partners
- 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 in 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 due diligence processes and qualification of new vendors or services
- Domain Expert within GCP and/or GCLP by peers with a strong interest and ability to educate others
Benefits
- A competitive salary of $120,000 - $150,000 per year, depending on location and experience
- A comprehensive benefits package, including health insurance, retirement plan, and paid time off
- Ongoing professional development opportunities and training
- A hybrid work environment with flexible remote work options
About Genmab
Genmab is a fast-growing biotechnology company dedicated to transforming the lives of patients through innovative cancer treatment. We pride ourselves on our commitment to scientific excellence, patient-centricity, and teamwork. If you are passionate about making a difference in the lives of patients and want to be part of a dynamic and innovative team, we encourage you to apply.
