R&D Quality CMC Lead
Toronto, Canada, Marcy-l'Étoile, France, Swiftwater, Pennsylvania
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Our Sanofi Pasteur Swiftwater, PA site, where we both research and manufacture vaccines since 1897, has had a tremendous impact on global health and the quality of human life. Nestled among the Pocono Mountains in Swiftwater, Pennsylvania, Sanofi Pasteur is home to state-of-the-industry facilities—and a rich and unique history. Our Swiftwater campus is more than 500 acres, housing 44 buildings and encompassing more than one million square feet of building space. Many of our facilities, while bright and modern, still retain the rustic charm of the original stonework.
Health & Wellness
Comprehensive coverage including medical, dental, vision, and health and wellness programs.
Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.
At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.
Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.
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Reference No. R2659229
Position Title: R&D Quality CMC Lead
Department: Vaccines Global R&D SQO
Sanofi Pasteur: The world’s leading vaccine company
Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines. Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines. Our company distributes more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe. Sanofi Pasteur offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
This position is a Quality Expert role that provides an integrated Quality strategy and decision making for VCDS programs within vaccine R&D. It reports directly to the Global Head of R&D Quality. The Quality Expert is responsible to ensure R&D Quality provides effective and efficient input to CMC teams, has oversight and input to manage Quality issues, and ensures alignment with current regulatory requirements and company expectations. He or she will coordinate VCDS-related quality activities according to CMC development from early GLP toxicology studies to late-phase clinical studies. This includes providing leadership and direction for work activities of CMC Project Team Quality representatives in R&D Site Quality functions. In addition, he or she will act as a primary interface with vaccine Industrial Affairs Quality and/or CMObased organizations for late-phase manufacturing compliance topics, including support for transfer to an industrial setting for launch. Quality Due Diligence for major partnerships and or acquisitions will also under their responsibility.
Ensures Sanofi quality standards and current regulatory requirements are integrated into VCDS project development plans and provides support /expertise for implementation of Quality processes and systems as needed.
Leads a CMC Quality sub-team for VCDS programs to coordinate and optimize activity across sites and quality functions in R&D. This may include as hoc vaccine Industrial Affairs Quality and external partners as needed, pending development plan needs and clinical phase.
Ensures quality deliverables are maintained on-track and monitors progress of notified deviations and impactful change controls, providing expertise for investigations, CAPA and action plans. Ensures sound risk management practices are in place and provides early management alerts for major quality issues and risks.
Provides input and decision making at CMC committees for topics with Quality impact, reviews key compliance documents such as specifications, stability program, comparability protocols, and inputs to CMC portion of regulatory submission documents to ensure consistency across phase and program.
Engages internal stakeholders to deliver external CMO engagement and QA oversight across different phases and programs, ensuring activities remain aligned to NV project strategy and timing.
Ensures compliance with and application of HSE rules and procedures, supports deployment and monitoring of R&D PASS program and initiatives to reduce environmental impact within R&D.
Reports any incidents or safety concerns in a timely manner and completes the appropriate documentation in a timely manner.
This position requires an in-depth understanding of quality regulations and guidelines applicable to vaccines development activities, strong leadership attributes, and excellent interpersonal, communication and facilitation skills. The incumbent will work in a cross-functional, team-oriented organization with individuals from multiple R&D functions and Sanofi Quality units in different geographies and countries in order to implement quality and compliance practices and oversee timely delivery of QA contributions and activities for early to late-phase VCDS NV projects. The ability to negotiate and communicate in a positive manner, to discuss and address quality issues, anticipate globally the impact of known risks, and develop effective, pragmatic solutions is a requirement of the position. Rapid prioritization and decision-making for timely resolution of issues identified with the manufacturing or testing of clinical batches is essential, and decisions the individual may make are based on multiple sources of technical information that will require sound investigation and effective interpretation. Familiarity with core vaccine manufacturing and testing requirements across the development process is necessary. Direct interaction with R&D external partners and CMO organizations is part of the role and requires interface with Alliance Management and Legal functions, plus appreciation for relationship building to support and enable vaccine business needs.
Breadth of responsibility: This role covers global, country and site interfaces for expertise and decision - making for R&D GXP Quality Assurance at internal and external manufacturing/testing operations. It covers all NV projects under VCDS responsibility. Key dimensions: Independent contributor with accountability for building Quality strategy and compliance expectations associated to the proposed NV Projects. Can impact the direction and delivery of NV Vaccine Projects. Oversees the contributions and work activities of CMC Quality Project Team representatives Representative for Quality Due Diligences.
PhD, MSC or equivalent in scientific discipline with 10 or more years in pharmaceutical/vaccine Quality Assurance.
5+ years of direct management in a relevant function at site or global level.
Demonstrated leadership with experience in developing and mentoring personnel.
Current and in-depth working knowledge of quality regulations and guidelines applicable to R&D vaccine activities.
Thorough understanding of end-to-end vaccine development and application of QbD.
Demonstrated understanding and practical application of Quality Risk Management.
Experience and demonstrated competence in use of Pharmaceutical Quality Systems associated to clinical phase manufacturing.
Demonstrates Play to Win Behaviors: Stretch, Take Action, Act for Patients & Customers, Think Sanofi First.
Strong organizational, planning and prioritization with effective problem solving and decision making ability.
Excellent communication (written and oral), negotiation and influencing skills.
Ability to build and maintain efficient professional relationships with partners and stakeholders.
Ability to operate in a cross-cultural and complex organizational matrix.
Ability to be self-driven and capable of working on own initiative.
Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request.
Thank you in advance for your interest.
Only those candidates selected for interviews will be contacted.
Sanofi, Empowering Life
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.