Sanofi Group Director, Research & Development, Quality North America in Toronto, Ontario

Job Title: Director, R&D Quality North America

Business Unit: R&D Quality and Innovation

Location: Toronto

Reporting to:Global Head, R&D Quality

Direct Reports : 5

Summary

The head of Research and Development (R&D) Quality for North America is responsible for GXP Quality Assurance activities at Sanofi Pasteur sites in Canada and the USA, including Toronto, Swiftwater, Cambridge and Orlando.

Reporting to the global head of R&D Quality, this individual provides leadership and direction for quality and compliance systems under GMP, GLP and GCLP, and ensures that effective quality practices are developed and maintained to support manufacturing, testing and supply of compliant clinical trial materials. This position directly manages the R&D SQO Toronto and Swiftwater departments.

Key Accountabilities:

Management of R&D Site Quality Systems, while optimizing collaboration with global R&D Quality and local and global IA Quality

  • Defines local quality programs for Toronto and Swiftwater sites to establish and improve Quality Systems within R&D.

  • Provides direction, guidance and education to R&D with regards to quality and compliance (GMP/GLP) for development of IND products to ensure full compliance with regulatory agency registered dossiers and Sanofi Quality documents.

  • Provides direction and guidance to Global Clinical Immunology (GCI) with regards to quality and compliance (GCLP) for clinical laboratory testing of patient samples in primary and secondary endpoint analyses of vaccine clinical trials.

  • Develops/revises policies and directives and other quality system business processes as assigned.

  • Minimizes risk to company through adherence to quality system requirements, and harmonization of compliance practices within various platforms of R&D and among the QA groups (R&D and IO), as local practices permit

  • Works with functional leaders to anticipate risks and assist in development of appropriate risk management plans.

  • Participates and contributes to site and above site Quality Councils, and site business reviews to ensure Management is appropriately informed and aware of the suitability and effectiveness of the quality system and significant events.

Ensure the release of clinical trial material and components for New Vaccine (NV) Products

  • Ensures local GMP QA representation for CMC Project Teams in NA to support SP R&D New Vaccine Portfolio

  • Assure timely reviews of executed Batch Production Records for seeds and clinical research material (Drug Substance, Drug Product) to ensure that documentation is both complete and compliant to referenced SOPs, cGMP’s, and IND commitments as applicable.

  • Assure Quality support to sites to complete investigations, change controls, deviations and CAPAs

  • Ensures reviews of non-conformance investigation reports for adequacy, and assures approval of final investigation reports and clinical batch / material disposition

  • Assures timely release of compliant clinical material

  • Ensure adequate quality audit and oversight of CMO-contracted GMP manufacturing operations for R&D NV projects

Site Quality Team Management

  • Manages through direct report the quality and compliance functions at Toronto and Swiftwater sites, and provides compliance support and oversight for Cambridge and Orlando sites.

  • Plans and coordinates R&D SQO team activities and priorities according to company goals and objectives.

  • Responsible to employ, develop, lead and motivates an empowered team of quality professionals capable of high performance, aligned decision-making, and reliable delivery of clinical trial materials.

  • Ensures good communication with staff, establishing clear performance expectations/evaluation and providing regular feedback. Determines merit salary actions for staff and ensures remedial action for staff whose performance does not meet standards.

  • Develops regional budget and headcount needs, and ensures aligned spending and use of resources to achieve optimal levels of compliance in the region.

Audits and Inspection Readiness

  • Provides leadership on the management of self-inspections for Toronto and Swiftwater to check effectiveness of the quality system

  • Provides leadership and direction for management of third party/external audits.

  • Provides leadership in the management of internal audits, and if applicable, regulatory inspections

  • Provide direction, guidance and education to ensure site audit/inspection readiness and oversee generation of written responses and associated corrective actions (CAPA)

Continuous Improvement – Performance – Quality Culture

  • Develops and monitors site quality metrics and reports these periodically to senior management through established Sanofi and Sanofi Pasteur processes and systems.

  • Defines annual site evaluation and improvement programs, based on quality metrics for R&D performance of GXP-related activities. Provides support for such improvement activities and follow up on applicable corrective actions.

  • Defines initiatives for continuous improvement of quality systems in R&D, according to Sanofi quality documents, corporate objectives, local programs, and in alignment with IA Quality as applicable.

  • Creates and maintains a high level of commitment to quality and compliance, and promotes a quality culture mindset to drive performance

Oversees compliance with Employment and Health & Safety

  • Oversees and monitors compliance with employment and health and safety legislation to ensure staff awareness and training on policies, procedures and regulations applicable to their work at both Toronto (CA) and Swiftwater (US) sites.

Major Responsibilities

  • This position requires an ability to evaluate potential, perceived or actual non-compliance to GMP/GLP/GCLP regulations, SOPs, local/international standards, and scientific practices. Required information is obtained through interviews, review of audits and of site and/or functional practices and requires developing relationships with stakeholders that promote open exchanges and a team environment.

  • Decisions made have a direct impact on quality of our clinical trial materials, studies and submissions, and may prevent patient health hazards, negative regulatory actions, and adverse publicity.

  • This position requires an ability to quickly evaluate and resolve rapidly changing and potentially conflicting priorities for aggressively planned project timelines. Thus there is a need for flexibility, adaptability, effective communication and problem-solving, whilst keeping all impacted parties informed.

  • The position requires an ability to be viewed as a pro-active contributor within R&D, helping to build quality into the processes and products, and establishing quality as a trusted partner and leader in compliance and customer service.

  • The ability to manage two site Quality teams in two countries (CA & US), and to ensure seamless communication of issues, concerns, and proposed resolutions for implementation, as well as alignment with global and local policies and procedures

Requirements:

Education/Certifications

  • Bachelor’s Degree in scientific/technical discipline. Advanced degree desirable but not required.

Experience

  • Prior experience in a quality leadership position or >10 years progressive management experience with GMP responsibilities within the vaccine and/or pharmaceutical industry.

  • Experience in vaccine or biologics development and/or commercial development operations, including first-hand knowledge of QA/QC and regulatory compliance.

  • Proven experience in Quality System Management.

  • Excellent knowledge of current GxP and Regulatory requirements applicable to vaccines

  • Strong organizational skills; ability to prioritize and manage through complex processes/projects

  • Managing within a global organization, embracing diverse cultures and employees.

  • Excellent communication and interpersonal skills. Fluent professional practice of English.

  • 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 is an equal opportunity employer committed to diversity and inclusion. Our goal is to a ttract, 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.

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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.

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.

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