Director QA Operations
Regeneron
August 10, 2026
On-site
Rensselaer, NY
Operations
Director, Quality Assurance (Drug Substance)
Responsibilities:
- Build and execute business strategy translating vision/corporate goals into departmental objectives.
- Build and lead a high-performing QA DS team; set priorities, goals, and objectives.
- Provide direction and performance standards; evaluate, develop, and inspire direct reports.
- Ensure QA floor staff training; identify and resolve risks; oversee in-process testing, line clearance checks, batch record review, return-to-service readiness, and first-response quality actions.
- Provide career development, training advice, and regular feedback.
- Direct activities of internal resources and contractors/vendors.
- Lead cross-functional teams; manage project deliverables within timeline, quality, and budget; interface with senior management on milestones and needs.
- Provide escalated response to quality/compliance issues on the manufacturing floor.
- Oversee/approve deviations and other quality events; protocols/reports; change documentation/SOPs; master batch record approval.
- Ensure product/facility/equipment holds when integrity is questioned.
- Interface with auditors during regulatory inspections; ensure periodic informal audits.
- Track quality activities/metrics and CAPA; analyze trends to drive process improvements.
- Support procedure/process development for cell culture, centrifugation/harvest, chromatography, UFDF, viral clearance, aseptic dispensing, filling batch records, and segregation/hold.
- Lead teams to maintain inspection readiness; influence others and challenge status quo.
Qualifications:
- Bachelor’s degree in Life Sciences or related field (or equivalent education/experience).
- 12+ years in Quality Operations/Quality Management or manufacturing in late/early-stage start-up drug substance/biologics.
Benefits/SALARY (as stated):
- Salary range (annually): $172,200.00 - $286,900.00.
Application:
- Apply now.
Responsibilities:
- Build and execute business strategy translating vision/corporate goals into departmental objectives.
- Build and lead a high-performing QA DS team; set priorities, goals, and objectives.
- Provide direction and performance standards; evaluate, develop, and inspire direct reports.
- Ensure QA floor staff training; identify and resolve risks; oversee in-process testing, line clearance checks, batch record review, return-to-service readiness, and first-response quality actions.
- Provide career development, training advice, and regular feedback.
- Direct activities of internal resources and contractors/vendors.
- Lead cross-functional teams; manage project deliverables within timeline, quality, and budget; interface with senior management on milestones and needs.
- Provide escalated response to quality/compliance issues on the manufacturing floor.
- Oversee/approve deviations and other quality events; protocols/reports; change documentation/SOPs; master batch record approval.
- Ensure product/facility/equipment holds when integrity is questioned.
- Interface with auditors during regulatory inspections; ensure periodic informal audits.
- Track quality activities/metrics and CAPA; analyze trends to drive process improvements.
- Support procedure/process development for cell culture, centrifugation/harvest, chromatography, UFDF, viral clearance, aseptic dispensing, filling batch records, and segregation/hold.
- Lead teams to maintain inspection readiness; influence others and challenge status quo.
Qualifications:
- Bachelor’s degree in Life Sciences or related field (or equivalent education/experience).
- 12+ years in Quality Operations/Quality Management or manufacturing in late/early-stage start-up drug substance/biologics.
Benefits/SALARY (as stated):
- Salary range (annually): $172,200.00 - $286,900.00.
Application:
- Apply now.