Director Quality Assurance, Drug Substance Manufacturing
Regeneron · Saratoga Springs
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Where this listing comes from
This listing was compiled by RoleLantern from the employer's publicly available posting on Workday, captured and rephrased by RoleLantern using automated (AI) tools on 2026-10-04 (originally posted 2026-09-15). It was not submitted or confirmed by the employer through RoleLantern. Details may be inaccurate, incomplete, outdated, or no longer available; please confirm with the employer's official posting before applying.
What they're looking for
- Bachelor's degree in life sciences, engineering, or related field
- 12+ years quality operations, management, or cGMP biologics manufacturing experience
- 4+ years in a leadership role
- Facility startup, commissioning, qualification, and process validation experience
- Automation systems knowledge (MES, DCS/SCADA, data integrity)
- Review-by-exception quality model experience preferred
- Cell culture, chromatography, UFDF, and aseptic dispensing operations knowledge beneficial
What you'll be doing
- Lead QA startup strategy including quality systems build-out, staffing, and facility readiness
- Define automation, systems integration, and data integrity requirements for review-by-exception batch disposition
- Build and manage high-performing QA team with performance standards and career development
- Establish data integrity governance ensuring ALCOA+ and 21 CFR Part 11 compliance
- Oversee regulatory inspections and maintain inspection readiness for newly commissioned facility
Privacy & handoff
This role links to Regeneron's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.