Job Title: Site Quality Head, R&D

Location: Swiftwater, PA

Provides site leadership and direction to R&D for quality and compliance systems in order that quality practices are developed and maintained for clinical testing laboratories in GCI and for early phase manufacture, testing, and release of clinical trial materials performed internally at Swiftwater or with external CMO/CRO partners

Main Responsibilities

Directs a small team of quality professionals to ensure effective GxP compliance programs are in place in site. Vaccines R&D functions, based on Global R&D Quality strategy, and in accordance to applicable regulations and company standards. Accountable for unit performance based on company, quality and project objectives, and for development of an Annual Quality Plan based on site performance metrics. Responsible to promote a quality culture mindset that ensures compliance and drives quality continuous improvements.

Represents Vaccines R&D Quality Swiftwater on the R&D Quality Leadership Team to establish priorities, define initiatives for improvement, develop and manage the budget. Acts as a subject matter expert for local R&D functions on quality -related topics.

1. 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

2. 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

3. Audits & Inspections

• 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

4. Continuous Improvement & Quality Culture

• 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

5. Community of Practice (CoP) Participation

• 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

6. Health, Safety & Compliance

• Oversee compliance with employment, health, and safety legislation
• Respond promptly to safety concerns/incidents and support investigations
• Complete appropriate documentation in a timely manner

Key Context & Challenges

• Manage quality and compliance for clinical trial material (CTM) 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

About You

Education:

• Minimum Bachelor of Science Degree, specializing in Biology, Microbiology, Biochemistry or related fields OR
• 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)

Experience & Technical Skills:

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

Preferred Qualifications:

• 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 are all assets

Skills and Competencies:

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

Why Choose Us

• 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 it's 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 least 14 weeks' gender-neutral parental leave.
• Work at the forefront of AI-driven research, smart manufacturing, and groundbreaking mRNA platforms that are redefining the future of immunology.
• Help protect half a billion people every year, contributing to one of the largest global vaccination efforts in healthcare.
• Develop your career with access to mentoring, international mobility programs, and opportunities to grow across four continents.

The salary range for this position is:
$133.500,00 - $192.833,33

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.