Director, Quality Control - Vaccine
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Title: Director, Quality Control - Vaccine
Reference No: R2584567
Location: Toronto, Canada
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.
The Director of Quality Control at Sanofi Pasteur is accountable for providing scientific and technical guidance on all test issues, QC support to commercial productions, product launches and project teams; employee enrichment and development; budget development/management; Maintaining a high level of Regulatory Compliance, effectively supporting the marketed product supply chain and serving as the QC liaison with groups/agencies external to the location.
Provide Leadership and direction to QC staff to ensure QC tests and procedures are aligned with CFRs and regulatory, global and internal guidelines.
Provides direction and interpretation on QC testing issues for all incoming in-process, final and in-development products. Ensures testing and release services are provided to Production and R&D in support of established schedules.
Provide expertise and support to regulatory inspections including quality representation on all activities / topics involving QC Testing
Establishes departmental objectives to align with site objectives for safety, quality, productivity, cost, and continuous improvement.
Builds and maintains 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.
Builds strong relationship with OMCLs for the continuous discussion of assay techniques and management of Out of trend or specification results.
QC liaison from/to Industrial Affairs
Meet QC department goals and metrics including adherence to financial budget
The incumbent will make decisions regarding the QC Testing activities and interpretation of cGMPs and industry guidance to achieve required compliance levels. Position has a high degree of autonomy and is expected to make decisions and interpretations within broadly defined requirements.
Education and experience
A minimum Masters Degree in science or a related field with 10-15 years of experience in a cGMP environment with a good understanding of overall business operations knowledge including at least 5 years experience in a regulated Quality environment is required. An advanced degree DVM/PhD is desireable.
Key technical competencies and soft skills:
Strong GMP background including working knowledge of GLP/GMP.
Strong management, supervisory, and both written and oral communications skills
Strong analytical and balanced decision making skills
Ability to understand role's impact and influencing skills
Diverse business, quality, and industrial manufacturing knowledge base
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.
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