Site Quality Head, R&D
Sanofi
July 02, 2026
On-site
Swiftwater, PA
$133,500 - $192,833.33 USD yearly
Operations
Main Responsibilities
- Provide site leadership and direction for R&D quality and compliance systems for clinical testing laboratories and early-phase clinical trial material manufacturing/testing/release (internal and via CMO/CRO partners).
- Direct 3–5 quality professionals to ensure effective GxP compliance; develop and maintain an Annual Quality Plan based on site performance metrics.
- Represent Vaccines R&D Quality Swiftwater on the R&D Quality Leadership Team: set priorities, define improvement initiatives, and develop/manage budget; act as quality SME for local R&D.
- Quality systems management: educate and guide on GLP/GCP/GMP; liaise with Quality Risk Manager for risk mapping/remediation; collaborate with global R&D Quality and local Manufacturing & Supply Quality.
- Audits/inspections: lead readiness for internal/external/third-party audits; ensure quality oversight of third-party suppliers/subcontractors (incl. quality agreements); defend quality programs and respond to audit findings.
- Continuous improvement/quality culture: support quality system improvements; report quality metrics; define annual evaluation programs; support corrective actions.
- Community of Practice: implement standardized local processes/tools; act as “Voice of Customer”; share best practices and propose improvements.
- Health, Safety & Compliance: oversee compliance with employment/health/safety legislation; respond to safety incidents and support investigations; complete required documentation.
Qualifications
- BS in Biology/Microbiology/Biochemistry (or related) OR MSc/PhD in Immunology/Microbiology/Biochemistry (or related).
- 10+ years relevant experience (preferably pharma/biotech), with substantial supervisory experience.
- Excellent knowledge of GMPs (US, Canada, Europe).
Preferred
- Familiarity with GLP, GCP, and GCLP; analytical method/equipment qualification knowledge.
- ASQ or ISO Certified Auditor; quality system certification training.
Skills
- Strong problem solving, report writing, and communication.
Benefits (explicit)
- High-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave; mentoring and international mobility programs.
- Provide site leadership and direction for R&D quality and compliance systems for clinical testing laboratories and early-phase clinical trial material manufacturing/testing/release (internal and via CMO/CRO partners).
- Direct 3–5 quality professionals to ensure effective GxP compliance; develop and maintain an Annual Quality Plan based on site performance metrics.
- Represent Vaccines R&D Quality Swiftwater on the R&D Quality Leadership Team: set priorities, define improvement initiatives, and develop/manage budget; act as quality SME for local R&D.
- Quality systems management: educate and guide on GLP/GCP/GMP; liaise with Quality Risk Manager for risk mapping/remediation; collaborate with global R&D Quality and local Manufacturing & Supply Quality.
- Audits/inspections: lead readiness for internal/external/third-party audits; ensure quality oversight of third-party suppliers/subcontractors (incl. quality agreements); defend quality programs and respond to audit findings.
- Continuous improvement/quality culture: support quality system improvements; report quality metrics; define annual evaluation programs; support corrective actions.
- Community of Practice: implement standardized local processes/tools; act as “Voice of Customer”; share best practices and propose improvements.
- Health, Safety & Compliance: oversee compliance with employment/health/safety legislation; respond to safety incidents and support investigations; complete required documentation.
Qualifications
- BS in Biology/Microbiology/Biochemistry (or related) OR MSc/PhD in Immunology/Microbiology/Biochemistry (or related).
- 10+ years relevant experience (preferably pharma/biotech), with substantial supervisory experience.
- Excellent knowledge of GMPs (US, Canada, Europe).
Preferred
- Familiarity with GLP, GCP, and GCLP; analytical method/equipment qualification knowledge.
- ASQ or ISO Certified Auditor; quality system certification training.
Skills
- Strong problem solving, report writing, and communication.
Benefits (explicit)
- High-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave; mentoring and international mobility programs.