Director Quality Assurance, Drug Substance Manufacturing
Regeneron
August 06, 2026
On-site
Saratoga Springs, NY
Operations
Responsibilities:
- Lead QA startup strategy for a Saratoga Drug Substance facility (quality systems build-out, staffing, readiness for design review, commissioning, qualification, process validation).
- Define automation, systems integration, and data integrity requirements (MES, DCS/SCADA, historian, LIMS) to enable review-by-exception batch record disposition.
- Partner with Automation, Engineering, and IT/Data Integrity to design exception-based quality control (electronic batch record rules, automated in-process checks, real-time release criteria).
- Build departmental objectives for a highly automated “plant of the future”; build/maintain a high-performing QA leadership team.
- Set performance standards; develop and inspire direct reports; raise the bar for departmental performance.
- Train manufacturing quality staff for an automated, review-by-exception environment (exception review, in-process testing oversight, batch record review; shop-floor quality first response).
- Establish data integrity governance (ALCOA+, 21 CFR Part 11/Annex 11 compliance from startup).
- Direct internal/external resources supporting digital startup and automation design.
- Lead cross-functional teams and deliverables for assigned projects within timeline/quality/budget; interface with senior management on milestones.
- Ensure policies/procedures/standards are established and followed; develop new quality systems for fully automated operations.
- Provide first response for Quality/Compliance issues; review/final QA approval of deviations and quality events; approve master batch records including automation/system-based release logic.
- Ensure holds for product/facility/equipment when integrity is questioned.
- Interface with auditors during regulatory inspections (including automation/data integrity); ensure periodic informal audits.
- Track quality metrics/CAPA and assess data trends for continuous improvement.
- Implement/improve operational and strategic quality policies.
- Support program development for cell culture, centrifugation/harvest, chromatography, UFDF, viral clearance, aseptic dispensing in an automated environment.
- Maintain constant inspection readiness.
Qualifications:
- Bachelor’s degree in Life Sciences, Engineering, or related field; 12+ years in Quality Operations/Quality Management/manufacturing in cGMP biologics/Drug Substance.
- 4+ years in a leadership role.
- Required: facility startup, commissioning, qualification, and process validation for greenfield/new manufacturing facilities.
- Highly preferred: automation systems (MES, DCS/SCADA), data integrity requirements, and review-by-exception quality models.
- Beneficial: cell culture, centrifugation, chromatography, UFDF, aseptic dispensing.
Application instructions:
- Apply now.
- Lead QA startup strategy for a Saratoga Drug Substance facility (quality systems build-out, staffing, readiness for design review, commissioning, qualification, process validation).
- Define automation, systems integration, and data integrity requirements (MES, DCS/SCADA, historian, LIMS) to enable review-by-exception batch record disposition.
- Partner with Automation, Engineering, and IT/Data Integrity to design exception-based quality control (electronic batch record rules, automated in-process checks, real-time release criteria).
- Build departmental objectives for a highly automated “plant of the future”; build/maintain a high-performing QA leadership team.
- Set performance standards; develop and inspire direct reports; raise the bar for departmental performance.
- Train manufacturing quality staff for an automated, review-by-exception environment (exception review, in-process testing oversight, batch record review; shop-floor quality first response).
- Establish data integrity governance (ALCOA+, 21 CFR Part 11/Annex 11 compliance from startup).
- Direct internal/external resources supporting digital startup and automation design.
- Lead cross-functional teams and deliverables for assigned projects within timeline/quality/budget; interface with senior management on milestones.
- Ensure policies/procedures/standards are established and followed; develop new quality systems for fully automated operations.
- Provide first response for Quality/Compliance issues; review/final QA approval of deviations and quality events; approve master batch records including automation/system-based release logic.
- Ensure holds for product/facility/equipment when integrity is questioned.
- Interface with auditors during regulatory inspections (including automation/data integrity); ensure periodic informal audits.
- Track quality metrics/CAPA and assess data trends for continuous improvement.
- Implement/improve operational and strategic quality policies.
- Support program development for cell culture, centrifugation/harvest, chromatography, UFDF, viral clearance, aseptic dispensing in an automated environment.
- Maintain constant inspection readiness.
Qualifications:
- Bachelor’s degree in Life Sciences, Engineering, or related field; 12+ years in Quality Operations/Quality Management/manufacturing in cGMP biologics/Drug Substance.
- 4+ years in a leadership role.
- Required: facility startup, commissioning, qualification, and process validation for greenfield/new manufacturing facilities.
- Highly preferred: automation systems (MES, DCS/SCADA), data integrity requirements, and review-by-exception quality models.
- Beneficial: cell culture, centrifugation, chromatography, UFDF, aseptic dispensing.
Application instructions:
- Apply now.