Senior Audit Manager
7 days ago
The Regeneron Senior Manager, Auditing, is a key position in the Global Development Quality Assurance (GDQA) group, providing guidance and leadership for Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance (GVP), and Computer System Validation (CSV) audit functions. This individual will create strategic partnerships and execute risk-based quality auditing activities across GDQA, applying expertise in GCP, GLP, GVP, and CSV to address complex GxP compliance issues.
Key Responsibilities:- Lead audits of higher complexity, including directed audits, and have a deeper level of knowledge and experience in conducting all audit types.
- Support the development and execution of departmental goals and objectives, and assist with the training and mentoring of audit staff.
- Identify internal quality/compliance issues and act as a catalyst for 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.
- May support clinical studies as study representative to develop and execute risk-based audit programs for assigned studies (GCP).
- Interpret and assist in developing policies and standards, and evaluate potentially critical problems not covered by policies, standards, and regulations.
- May provide education, mentoring, and/or training to GDQA and other relevant Global Development departments.
- May 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.
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Uxbridge, United Kingdom Regeneron Pharmaceuticals Inc. Full timeJob Title: Senior Audit ManagerThe Regeneron Senior Manager, Auditing, is a key position in the Global Development Quality Assurance (GDQA) group, providing guidance and leadership for Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance (GVP), and Computer System Validation (CSV) audit functions. This individual will create...
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