Senior Audit Manager
4 weeks ago
Regeneron is seeking a highly experienced Senior Audit Manager to join our Global Development Quality Assurance (GDQA) team. As a key member of our team, you will provide guidance and leadership for Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance (GVP), and Computer System Validation (CSV) audit functions.
Key Responsibilities:- Lead the identification of internal quality/compliance issues and drive process improvements to promote standardization and best practices within GDQA and across Regeneron.
- Represent GDQA on high-value and complex teams, compliance projects, and initiatives within and across functional areas or other departments.
- Develop and execute risk-based audit programs for assigned studies (GCP) and support clinical studies as a study representative.
- Interpret and assist in developing policies and standards, and evaluate potentially critical problems not covered by policies, standards, and regulations.
- Provide education, mentoring, and/or training to GDQA and other relevant Global Development departments.
- Participate in regulatory inspections by acting as part of the control and/or inspection room team.
- Bachelor's degree (Master's degree preferred) with 8+ years of relevant industry experience.
- 5+ years of direct GCP, GLP, and/or GVP audit experience preferred.
- Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors, or CROs.
- Strong track record of project management, stakeholder management, collaboration skills, and negotiation of complex situations.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.
The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
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