Senior Director, Global Development Quality Assurance (GLP)
Regeneron
8 hours ago
On-site
Tarrytown, NY
Operations
Responsibilities:
- Lead an entire GLP function and manage GDQA staff.
- Develop and execute a strategic plan for GLP audit functions.
- Create/oversee strategic partnerships and implement risk-based quality auditing internally and with external organizations.
- Manage the GLP audit function within GDQA; oversee development, execution, and reporting of GxP Audit Program(s).
- Identify internal quality/compliance issues; use metrics to diagnose and remediate systemic quality issues.
- Provide audit and compliance input in cross-functional and external meetings; represent GDQA on priority teams and complex initiatives.
- Oversee relevant policies/standards/regulations and evaluate potentially critical problems.
- Lead education/training for GDQA and other Global Development departments as needed; ensure succession planning and business continuity.
Qualifications & Required/Preferred Skills:
- Bachelor’s degree (Master’s preferred).
- 12+ years relevant industry experience; minimum 10 years GLP auditing and/or audit strategy.
- 6–8 years prior supervisory/leadership experience.
- Strong knowledge of FDA (and other) regulatory inspections for Investigator sites, Sponsors, or CROs.
- Demonstrated experience driving Quality into Clinical Trial Operations processes.
- Proven success leading a GLP Quality Assurance (GDQA) function; strong people/project management, collaboration, negotiation; able to manage multiple priorities with urgency.
On-site/Benefits & Location:
- On-site 4 days/week in Tarrytown, NY; no remote option. Relocation benefits may be available.
- Salary range (annual): $216,100.00–$360,200.00.
Application:
- Apply now.
- Lead an entire GLP function and manage GDQA staff.
- Develop and execute a strategic plan for GLP audit functions.
- Create/oversee strategic partnerships and implement risk-based quality auditing internally and with external organizations.
- Manage the GLP audit function within GDQA; oversee development, execution, and reporting of GxP Audit Program(s).
- Identify internal quality/compliance issues; use metrics to diagnose and remediate systemic quality issues.
- Provide audit and compliance input in cross-functional and external meetings; represent GDQA on priority teams and complex initiatives.
- Oversee relevant policies/standards/regulations and evaluate potentially critical problems.
- Lead education/training for GDQA and other Global Development departments as needed; ensure succession planning and business continuity.
Qualifications & Required/Preferred Skills:
- Bachelor’s degree (Master’s preferred).
- 12+ years relevant industry experience; minimum 10 years GLP auditing and/or audit strategy.
- 6–8 years prior supervisory/leadership experience.
- Strong knowledge of FDA (and other) regulatory inspections for Investigator sites, Sponsors, or CROs.
- Demonstrated experience driving Quality into Clinical Trial Operations processes.
- Proven success leading a GLP Quality Assurance (GDQA) function; strong people/project management, collaboration, negotiation; able to manage multiple priorities with urgency.
On-site/Benefits & Location:
- On-site 4 days/week in Tarrytown, NY; no remote option. Relocation benefits may be available.
- Salary range (annual): $216,100.00–$360,200.00.
Application:
- Apply now.