The Deputy Director Batch Disposition is responsible for final SAP batch disposition (release or reject) quality judgment at Finished Drug Substance Monovalent (including PPD Stock solution, Poliovirus Inactivated Monovalent, Trivalent and Adsorbed/Dispensed stage of manufacture), Filled Product and Finished Drug Product. This person’s role is vital as independent quality review of critical manufacturing and test data for each lot of vaccines is essential to assure the consistent quality of each manufactured lot before it is marketed.
- Batch Dispositions: Perform final SAP batch disposition (release or reject) quality evaluation at Finished Drug Substance Monovalent (including PPD Stock, Poliovirus Inactivated Monovalent, Trivalent and Adsorbed/Dispensed stage of manufacture), Filled Product and Finished Drug Product in accordance with standard operating procedures. This would apply to contract site manufactured Filled and Finished Drug Products that are registered or delegated to Toronto Canada by the license holder as indicated in product specifications and quality agreement. Ensure timely Quarantine on Hold Notification to external sites, product reallocation review and product return assessment.
- Management: Initiate and lead regional collaboration with Sanofi and MCM sites for alignment and drafting of product specifications for products imported or inter site manufactured products with Toronto as biological license holder through change control system. Review & approve SAP Inspection plans including material number, genealogy and expiry. Facilitate and support as point of contact for manufacturing transfer of marketed products and new product licensure to meet defined timelines for launch to market.
- Quality Systems & Projects: Maintain training to perform the designated cGMP activities and meet Health Safety and Environment requirements. Maintain Quality Systems (e.g. deviation, CAPAs, change controls, audits and inspections). Collaborate with Sanofi sites and support projects that improve safety, quality, delivery, cost, involvement and strategic priorities.
Scope and Dimensions
- An independent quality review of critical manufacturing and test data for each lot of vaccines is essential to assure the consistent quality of each manufactured lot before it is marketed. Escalation to Senior Management on quality events, resolution of conflicts and propose recommendations. Key spokesperson on batch disposition from request made during Regulatory Inspections. Provide rotational shift support if required by the business operations. Organize vacations with team to ensure one Deputy Director Senior Qualified Person is present on site.
- Excellent interpersonal and negotiation skills are critical as the position requires extensive interaction with both internal and external customers. The position is considered stressful due to the need to meet critical timelines for both internal customers and regulatory agencies.
Education and Experience
- Masters of Science Degree and or at least 8 years pharmaceutical cGMP experience (for US, Canada, Europe and International) with related Quality Batch Disposition (Release and Reject).
- Strong background in all stages of biological product manufacturing
- Excellent report writing and communication skills; demonstrated managerial skills and good judgement. Excellent interpersonal and negotiation skills are critical as the position requires extensive interaction with both internal and external customers.
- Minimum 3 years experience leading teams with a strong customer focus and ability to prioritize and readily adapt to business needs.
- Strong knowledge and understanding of Quality and current Good Manufacturing Practices (cGMP)
- Competence in systematically solving problems using appropriate process improvement methodologies to analyze complex data / information from different cross-functional teams, both locally and globally.
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.