Director, Quality Operations Capital Projects
Reference #: R2495481
Department: Site Quality Operations
Location: Toronto, Ontario
About Sanofi Pasteur
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.
- On-board and lead a staff of Permanent and Contract employees to ensure the B100 program is aligned with CFRs and regulatory, global and internal guidelines through the entire project life cycle from construction to registration.
- Provide guidance and technical support to the company for Quality related B100 project planning, process, systems and computer validation, aseptic processes, method validation and shop floor operations, problem investigations, product assessment, audit and Quality Controls test planning.
- Collaborate with senior colleagues in Quality Operations, Industrial Affairs, Regulatory Affairs, and globally to harmonize and improve processes or resolve problems on regulatory compliance issues.
- 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. Always respect project governance and escalation processed established for B100. Manage and direct a multi-disciplinary team involved in the entire project life cycle from (construction to registration) and planning ensuring appropriate competencies are in place to provide a continuously improving, efficient, innovative scientific resource. Supervise staff and manage risk in accordance with company commitment and appropriate policies and procedures.
- Raise compliance and quality issues and solutions/ proposals to senior management. Develop, maintain and control departmental capital and operating expense budgets.
- Provide expertise and support to regulatory inspections including quality representation on all activities / topics involving Quality Operations linked to the manufacturing process or environment for B100 project
- Establish B100 quality team objectives to align with site objectives for safety, quality, productivity, cost, and continuous improvement. Conduct regular performance appraisals and provide career development reviews and opportunities for staff when applicable based on reporting lines.
Bachelors in sciences or engineering. Masters preferred
- Strategic Direction - Establishing direction, proposals, and alternatives to assure business viability through sustained compliance, efficient systems and quality culture in full collaboration with the B100 project director.
- Collaborate with Site Quality head to build adequate capabilities within the QA organization for B100.
- Quality and Compliance - Leadership, design and implementation to improve Compliance and Quality Posture. This requires strategic planning/ vision as well as developmental and interpersonal skills. Challenges range from organizational issues to resource utilization impacting supply and developmental activities that need it be balanced amongst all business needs.
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.