Director of Quality Assurance GCP and PV
5 days ago
Genmab is seeking a highly motivated Director of Quality Assurance GCP and PV to join our global QA team. This role offers the opportunity to work in a fast-paced, dynamic environment with a talented team of professionals dedicated to delivering high-quality products.
About the Role
- This position will lead the development and implementation of quality assurance strategies and processes for GCP and PV, ensuring compliance with regulatory requirements.
- You will be responsible for planning, conducting, and reporting on quality audits within the GCP regulated areas.
- Mentor and train QA colleagues and Lead Auditors to increase the competency level across the global QA GCP & PV team.
- Collaborate with the Team Lead to develop and maintain audit strategies.
- Coordinate and lead GCP inspection readiness activities for FDA, EMA, and PMDA inspections.
- Participate in inspections and audits performed by partners.
- Develop and maintain the Genmab QMS with focus on GCP and GCLP requirements.
- Conduct internal GCP training.
- Deliver GCP advisory expertise within the company and to external vendors.
Requirements
- MSc in Natural Science or similar, with at least 5 years of profound experience in GCP and GCLP.
- Lead Auditor certification in 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 Veeva Vault QMS.
- Experience with due diligence and qualification of new vendors or services.
- Considered a Domain Expert in GCP and/or GCLP by peers.
Personal Requirements
- Strong analytical skills, combined with the ability to extract and apply into a tactical and strategic context.
- Ability to thrive in a setting with multiple complex tasks and shifting priorities.
- Pro-active and open-minded, a dedicated team player with excellent oral and written communication skills.
About Us
- We strive to create a collaborative work environment that fosters innovation, creativity, and excellence.
- Our employees enjoy a comprehensive benefits package, including health insurance, retirement plans, and paid time off.
- We offer a hybrid work arrangement, allowing you to balance your work-life responsibilities while contributing to our mission.
Salary Range
The salary range for this position is between $120,000 - $160,000 per year, depending on experience and qualifications.
Location
This role can be located in Copenhagen, Denmark, Utrecht, the Netherlands, or Princeton, New Jersey, U.S. We welcome applications from candidates who are willing to relocate.
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