Associate Director, CSV Auditing
Regeneron
4 months ago
Remote friendly (United States)
United States
IT
Responsibilities:
- Provide supervision, guidance, and leadership for Computer System Validation (CSV) Audit Programs.
- Create strategic partnerships and direct risk-based quality auditing activities.
- Ensure audits are implemented for GCP, GLP, and/or GVP audit teams.
- Lead/support development and execution of departmental goals and objectives; mentor and train new staff.
- Develop standards and audit methods to stay current with new technologies and advancements in clinical development to support an “end to end” audit process.
- Schedule, prepare, conduct, report on, and follow up routine and directed audits supporting GxP subject areas in accordance with SOPs and quality policies.
- Conduct internal and external audits globally.
- Participate in management of GDQA resources to accomplish annual audit schedules.
- Provide leadership, guidance, and supervision to staff.
- Assess and prioritize internal and external audit needs.
- Represent GDQA on high-priority/high-visibility teams, compliance projects, and initiatives to ensure compliance with related regulations and internal procedures.
- Provide training and mentoring to GDQA personnel and relevant departments.
- Draft and issue periodic metrics reports to management, cross-functional groups, and leadership teams.
- May assist in regulatory inspections and act as a subject matter expert.
Qualifications:
- Bachelor’s degree (Master’s degree preferred).
- 11+ years of relevant experience, including:
- 9 years auditing with CSV
- 3 years management experience
- Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors, or CROs.
- Expert knowledge of FDA and EU regulations and ICH guidance documents, and other regulations impacting drug development and post-authorization safety monitoring.
Required/Preferred Skills:
- Risk-based auditing and GxP audit program leadership.
- Leadership, mentoring, and staff supervision.
- Audit methodology and standards development.
- Subject matter expertise in regulatory inspections.
Travel:
- 30–40% travel (domestic and international).
Application instructions:
- Apply now.
- Provide supervision, guidance, and leadership for Computer System Validation (CSV) Audit Programs.
- Create strategic partnerships and direct risk-based quality auditing activities.
- Ensure audits are implemented for GCP, GLP, and/or GVP audit teams.
- Lead/support development and execution of departmental goals and objectives; mentor and train new staff.
- Develop standards and audit methods to stay current with new technologies and advancements in clinical development to support an “end to end” audit process.
- Schedule, prepare, conduct, report on, and follow up routine and directed audits supporting GxP subject areas in accordance with SOPs and quality policies.
- Conduct internal and external audits globally.
- Participate in management of GDQA resources to accomplish annual audit schedules.
- Provide leadership, guidance, and supervision to staff.
- Assess and prioritize internal and external audit needs.
- Represent GDQA on high-priority/high-visibility teams, compliance projects, and initiatives to ensure compliance with related regulations and internal procedures.
- Provide training and mentoring to GDQA personnel and relevant departments.
- Draft and issue periodic metrics reports to management, cross-functional groups, and leadership teams.
- May assist in regulatory inspections and act as a subject matter expert.
Qualifications:
- Bachelor’s degree (Master’s degree preferred).
- 11+ years of relevant experience, including:
- 9 years auditing with CSV
- 3 years management experience
- Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors, or CROs.
- Expert knowledge of FDA and EU regulations and ICH guidance documents, and other regulations impacting drug development and post-authorization safety monitoring.
Required/Preferred Skills:
- Risk-based auditing and GxP audit program leadership.
- Leadership, mentoring, and staff supervision.
- Audit methodology and standards development.
- Subject matter expertise in regulatory inspections.
Travel:
- 30–40% travel (domestic and international).
Application instructions:
- Apply now.