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QA Director, Clinical Development
3 weeks ago
We're looking for a highly motivated Senior Manager to join our QA team as a GCP lead auditor and trainer. In this role, you'll be responsible for developing and maintaining the audit strategies in collaboration with the Team Lead. You'll also coordinate and lead GCP inspection readiness activities for FDA, EMA, and PMDA inspections. Your expertise will be essential in mentoring new QA colleagues and experienced lead auditors to enhance the competency level across the global QA team.
About the Job:
This is an exciting opportunity to join our dynamic QA team and contribute to the development of innovative antibody medicines. If you're passionate about improving patient outcomes and have a strong background in GCP and GCLP, we encourage you to apply.
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.
