Site Quality Head, R&D

Role Overview

Provides site leadership and direction to R&D for quality and compliance systems to develop and maintain quality practices for clinical testing laboratories and early phase manufacture, testing, and release of clinical trial materials performed internally at Swiftwater or with external CMO/CRO partners.

Site Quality Head, R&D

Location: Swiftwater, PA

Directs a small team of quality professionals to ensure effective GxP compliance programs are in place at the site, with a focus on quality systems, audits, continuous improvement, and stakeholder collaboration.

• Quality Systems Management
• Provide direction, guidance, and education on quality and compliance (GLP, GCP, GMP) to ensure adherence to regulations and Sanofi policies
• Serve as primary liaison with Quality Risk Manager for site risk‑mapping and remediation
• Collaborate with global R&D Quality and local Manufacturing & Supply Quality
• Team Leadership (3–5 direct reports)
• Manage and coordinate the Swiftwater R&D Quality team's activities and priorities
• Establish performance expectations, provide regular feedback, and define skill enhancement programs
• Distribute workload to ensure timely deliverables
• Provide quality support and resources to R&D senior management
• Lead site inspection readiness for internal, external, and third‑party audits
• Ensure quality oversight of third‑party suppliers and subcontractors, including quality agreements
• Serve as subject‑matter expert during inspections, defending quality programs and providing timely responses to audit observations
• Support local and global quality system improvement initiatives
• Report site quality metrics to senior management across R&D functions
• Define annual evaluation programs based on quality indicators and metrics
• Support corrective action development and follow‑up
• Implement standardized processes and tools at the local level
• Act as "Voice of Customer" and provide feedback on roadblocks
• Share inspection experiences, best practices, and propose process improvements
• Contribute to CoP roadmap objectives
• Oversee compliance with employment, health, and safety legislation
• Respond promptly to safety concerns/incidents and support investigations
• Complete appropriate documentation in a timely manner

• Manage quality and compliance for clinical trial material manufacturing and testing, plus clinical sample laboratory oversight
• Stay current with changing regulatory environment and apply quality risk management approaches
• Defend programs during audits/inspections in a competent and convincing manner
• Requires strong organization, autonomy, decision‑making, and communication skills
• Interact with colleagues across multiple international sites
• Local accountability with potential global impact on R&D departments
• Minimal travel required for audits and global meetings

• Minimum Bachelor of Science Degree, specializing in Biology, Microbiology, Biochemistry or related fields
• Advanced Degree (MSc or PhD), specializing in Immunology, Microbiology, Biochemistry, or other relevant discipline

• 10+ years of relevant experience, ideally in Pharmaceutical/Biotech, with substantial supervisory experience managing teams and direct reports (highly preferred)

• Excellent knowledge of the GMPs for US, Canada and Europe

• Familiarity with GLP, GCP and GCLP
• Understanding of analytical method and equipment qualification
• ASQ Certified Auditor
• ISO Certified Auditor
• Quality System certification training from a recognized institution (assets)

• Excellent problem‑solving, report‑writing and communication skills based on global interaction

• Bring the miracles of science to life alongside a supportive, future‑focused team
• Discover endless opportunities to grow your talent and drive your career, whether through a promotion or lateral move, at home or internationally
• Enjoy a thoughtful, well‑crafted rewards package that recognizes your contribution and amplifies your impact
• Take good care of yourself and your family with a wide range of health and wellbeing benefits, including high‑quality healthcare, prevention and wellness programs and at…