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Senior Quality Assurance Lead
1 month ago
Genmab is a global biotech leader in the development of antibody products and pioneering therapies. We are committed to safeguarding patients and ensuring quality compliance in all aspects within Pharmacovigilance.
About the Role:
We are seeking a highly motivated Senior Quality Assurance Lead with at least 6 years of experience in auditing PV activities. As an experienced PV lead auditor, you will have the capabilities to train other auditors within Pharmacovigilance.
As a Senior Quality Assurance Lead, you will have in-depth scientific expertise within quality assurance and all regulatory requirements related to Pharmacovigilance activities. You will have strong analytical skills, high-quality standards, detail-oriented, and the ability to apply your expertise into a strategic context that enables you to identify solutions within agreed deadlines.
You will be working in a global team with QA colleagues located in the US, the Netherlands, Japan, and Denmark. Furthermore, you will be part of a strong cross-functional collaboration across the company.
Main Responsibilities:
- Plan, conduct, report, and follow up on quality audits within PV regulated areas.
- Develop and improve the PV audit strategy and drive the PV audit plan in collaboration with senior QA PV colleagues.
- Mentor QA colleagues and experienced lead auditors to increase competency levels across QA GCP & PV.
- Lead PV inspections readiness activities and PV partner audits.
- Coordinate and lead GCP inspection readiness activities for FDA, EMA, and PMDA inspections.
- Participate in inspections and audits performed by partners.
- Represent QA in the PV and Medical Affairs Process Expert Group.
- Participate or drive the development, maintenance, and improvement of the Genmab QMS with focus on PV requirements.
- Develop and execute internal training of PV requirements and deliver PV advisory expertise within the company and to external vendors.
Requirements:
- MSc in Natural Science or similar and at least 6 years of profound experience within auditing of Pharmacovigilance activities.
- Experienced Lead Auditor within PV preferable with in-depth knowledge related to outsourced safety processes and internal safety processes.
- Proficiency in Veeva Vault QMS will be an advantage.
- Experience with the due diligence process and qualification of new vendors or services.
- Considered as a Domain Expert within PV by peers and has a strong interest and ability to educate others.
Estimated Salary: €80,000 - €110,000 per year, depending on location and experience.
