Reference Number: R2572741
Position Title: Director, Product Quality
Department: Site Quality Operations
Location: Sanofi Pasteur Limited, Toronto, Ontario
Provides leadership and direction to ensure the Product Quality Department, including Batch Release, Material Release, Records and Systems, and Batch Record Review successfully meets objectives in support of corporate and site goals, and successfully operates within the regulatory environment.
Accountable for Batch Release, Lot Release Protocols and Disposition.
Evaluation and batch disposition of all products, quality managed components, and labelling.
Ensuring that all internal policies and procedures, and government regulations are met for disposition of lots while driving to meet dynamic product release timelines.
Ensure availability of product to domestic and international markets by the timely and accurate review and release of batch documents.
Hire and develop employees within the department providing feedback and coaching.
Lead end to end document management (site document management system, record retention program, Final Quality Review of all executed Batch Records).
Evaluate/approve all Master Batch Records, Master Specifications, department procedures, assuring compliance to global policies and government regulations; Final approver for all Master Product and Material Specifications.
Establish departmental objectives to align with site objectives for safety, quality, delivery, cost, involvement.
Build and maintain a high performing team, providing effective alignment and communication with functional groups at the site and at other manufacturing sites, to successfully deliver on all commitments. Effectively utilizes resources through staff development, performance management, recruiting, rewards and recognition.
Interact with global counterparts in a leadership or participant role. Interact regularly with regional counterparts on inter-site activities relating to manufacturing, testing, disposition and cold chain documentation.
Provide expertise and support to regulatory inspections.
Communicate GMP requirements and provide teams with guidance regarding incoming sampling, inspection, and lot disposition requirements.
Education and Experience:
Advanced Degree preferably in life sciences, with a minimum 10 years experience in a cGMP controlled/pharmaceutical industry, including at least 5 years experience in a regulated Quality environment.
QP certification preferred.
Excellent knowledge of cGMPs and regulatory requirements, experience interacting with health authority inspections, excellent organizational, interpersonal and leadership.
Experience with teamwork abilities, at least three years supervisory experience, a strong customer focus and ability to prioritize and readily adapt to business needs.
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.
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.