Associate Manager, QA Investigations
Regeneron
5 hours ago
On-site
Rensselaer, NY
Operations
Associate Manager, QA Investigations
Role Responsibilities
- Provide oversight of quality review and quality approval for deviation events, laboratory investigations, and CAPA.
- Manage a team with direct oversight of review and approval for deviations, laboratory investigations, and corrective actions.
- Review, verify, and approve system records.
- Collaborate across QA to support investigation teams and drive quality outcomes.
- Approve and review SOP revisions.
- Provide direction for cross-functional study team meetings and interact with subject matter authorities.
- Provide input for error prevention and corrective actions based on investigational findings.
- Manage post-production activities for events to facilitate timely closures.
- Serve as a subject matter authority to present topics to management and during inspections.
- Monitor quality system metrics (deviations, corrective actions, change management, and controlled document workflows).
- Draft and implement long-term planning for process, staff, and budget.
- Perform personnel management functions (annual evaluations, coaching, mentoring, performance feedback).
- Make decisions and develop and implement policies.
- Ensure policies and procedures are coordinated and follow regulatory requirements and current good manufacturing practices (cGMPs).
Qualifications
- BA/BS degree in Life Sciences or related field.
- 6+ years of relevant cGMP manufacturing experience.
- 3 years of supervisory experience.
- May substitute proven experience for education requirement.
Preferred/Role Fit
- Previous quality experience in the pharmaceutical industry.
- Continuous improvement mindset for process performance.
- Enjoy leading a team of quality-minded professionals.
Benefits (as stated)
- Comprehensive benefits vary by location; in the U.S. may include medical, dental, vision, life, and disability insurance; fitness centers; 401(k) company match; family support benefits; equity awards; annual bonuses; paid time off; and paid leaves.
Application Instructions
- Apply now.
Role Responsibilities
- Provide oversight of quality review and quality approval for deviation events, laboratory investigations, and CAPA.
- Manage a team with direct oversight of review and approval for deviations, laboratory investigations, and corrective actions.
- Review, verify, and approve system records.
- Collaborate across QA to support investigation teams and drive quality outcomes.
- Approve and review SOP revisions.
- Provide direction for cross-functional study team meetings and interact with subject matter authorities.
- Provide input for error prevention and corrective actions based on investigational findings.
- Manage post-production activities for events to facilitate timely closures.
- Serve as a subject matter authority to present topics to management and during inspections.
- Monitor quality system metrics (deviations, corrective actions, change management, and controlled document workflows).
- Draft and implement long-term planning for process, staff, and budget.
- Perform personnel management functions (annual evaluations, coaching, mentoring, performance feedback).
- Make decisions and develop and implement policies.
- Ensure policies and procedures are coordinated and follow regulatory requirements and current good manufacturing practices (cGMPs).
Qualifications
- BA/BS degree in Life Sciences or related field.
- 6+ years of relevant cGMP manufacturing experience.
- 3 years of supervisory experience.
- May substitute proven experience for education requirement.
Preferred/Role Fit
- Previous quality experience in the pharmaceutical industry.
- Continuous improvement mindset for process performance.
- Enjoy leading a team of quality-minded professionals.
Benefits (as stated)
- Comprehensive benefits vary by location; in the U.S. may include medical, dental, vision, life, and disability insurance; fitness centers; 401(k) company match; family support benefits; equity awards; annual bonuses; paid time off; and paid leaves.
Application Instructions
- Apply now.