Sanofi Group Director Product Quality- Toronto,ON in 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.
Key Duties and Responsibilities
Lead a team of direct reporting employees and coordinate with manufacturing and other support functions to ensure that the following key department objectives are successfully met:
Evaluation and batch disposition of all products, quality managed components, and labeling. Final Quality review of all executed batch records.
Review and approve annual internal audit schedule protocol and annual internal audit summary report.
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.
Evaluate Change Controls to identify impact to Product Quality functions, evaluate and approve department investigations for non-conformances assuring root cause is found and CAPAs are identified and executed.
Lead site document management system and record retention program.
Provide support for Regulatory inspections regarding Product Quality topics.
Develop, maintain and enhance procedures and systems for department functions to align with global policies and government regulations.
Lead or participate in site, regional, and global projects.
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.
Manages headcount and expenses in department to achieve site objective and meet budget expectations.
The incumbent must interact successfully within the highly energized production and regulatory environments.
The incumbent interacts regularly with regional counterparts on inter-site activities relating to manufacturing, testing, disposition and cold chain documentation.
The incumbent must be able to communicate clearly the cGMP requirements and provide teams with guidance regarding incoming sampling, inspection, and lot disposition requirements.
The incumbent must drive to meet dynamic product release times while ensuring that all internal policies and procedures, and government regulations are met for disposition of lots.
Improper release of product to market could result in lost sales, litigation or recall.
The incumbent has a critical role in developing and maintaining the site's HSE culture, by leading by example and creating an environment for robust HSE within area of responsibility.
The incumbent’s decisions have an impact on multiple work units, including Quality, Operations, Regulatory Affairs, R&D, Planning, Distribution, and Marketing. This position interacts with global counterparts, and will be involved in teams in a leadership or participant role.
This position must ensure availability of product for further manufacturing, and availability of product to domestic and international markets by the timely and accurate review and release of batch documents.
The incumbent hires and develops employees within the department including exempt and nonexempt staff, assigns work, provides feedback and coaching.
Bachelor's 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 .
Excellent knowledge of cGMPs and regulatory requirements, experience interacting with health authority inspections, excellent organizational, interpersonal and leadership / 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 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.
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.
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, Empowering Life