Job Description

Reference No. R2657393 Position Title: Manager R&D Site Quality Operations Department: Quality Operations Location: Sanofi Pasteur Limited, Toronto
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.
Position Summary: The Manager R&D Site Quality Operations (SQO) will provide, quality oversight for activities related to research and development for sterile manufacturing of vaccines for use in clinical trials, and will report to the Deputy Director R&D Site Quality Operations. Key Responsibilities:

• Ensures GMP R&D QA support for all development phases of new vaccines and technology projects, providing technical, quality and compliance expertise, risk-based, quality-decision making, and timely release of clinical trial material (CTM) and components.
• Responsible for the quality and compliance aspects and risks associated with the test method qualification, validation and testing, manufacturing, filling, of CTM in accordance with cGMP standards.
• Responsible for representing R&D SQO on key New Vaccine Project Teams and or working groups in order to provide direction on quality issues and regulatory compliance.
• Responsible for the review, assessment and, where applicable, the approval of original and revised procedures, master BPRs and executed BPRs detailing manufacturing of clinical trial materials, equipment operations, test and quality procedures, protocols and reports (validation, stability) for quality content and compliance to cGMPs.
• Support the co-ordination of investigation, root cause analysis and ensure timely closure and completion of Deviations, Change Controls and CAPAs, while making sure the right level of quality is maintained.
• Supports Manufacturing (including testing, release) R&D functions to ensure a constant state of inspection readiness, and ensures that audit observations are addressed quickly and completely
• Supports quality oversight of third party suppliers and sub-contractors, including development of quality agreements , conduct external audits and QTP management.
• Accountable for ensuring company policies , site procedures and standards are consistently met and implemented for R&D products, and that assigned areas meet current FDA and International Regulatory requirements.
• Responsible for maintenance of Quality Systems and able to partner and maintain strong alignment with local functional stakeholders and across global R&D Quality sites, and successfully deliver on project and continuous improvement commitments.

HSE Requirement/Statement

Works within the policies, procedures and regulations as required by the Company and under the Occupational Health and Safety Act.

Major Challenges

• The incumbent is responsible for managing the quality and compliance risks associated with the manufacturing and testing of clinical trial material (CTM) in accordance with cGMP standards, and regulatory and internal requirements.
• Familiarity with manufacturing processes, filling operations, cleaning, sanitization, sterilization techniques, aseptic techniques, cleanroom management and aseptic process control and all the relevant tests is fundamental in performing the job.
• The incumbent interacts with other internal auditors, and other site auditors, and corporate (or third party) auditors during audits related to R&D activities.
• This position requires a strong understanding of quality, and team leadership attributes as the incumbent will lead a team of individuals/professionals from various R&D and/or QO departments to resolve problems or implement quality systems. An ability to negotiate and communicate with people in a positive manner while identifying, discussing and rectifying problems is a requirement of the position. The nature of these relationships includes the range from senior management staff to direct line employees.
• A fundamental understanding of manufacturing processes, test methods and development products is necessary for auditing, identifying and investigating deviations from standards, and specifications for deficiencies in processes. Investigations involve overseeing evaluations for root cause analyses that lead to implementation of corrective and preventative actions (CAPA) that restore the compliance status of the errant process.
• The ability to facilitate and prioritize the issues identified with the manufacturing of CTM in a timely fashion requires flexibility, constructive and/or innovative thinking to resolve and manage the process.
• Decisions the incumbent may make are based on multiple sources that will require further investigation or interpretation. Work consists primarily of duties requiring resolution through the choice of several learned policies and procedures with respect to analytical assessments, innovative approaches, and the like. The incumbent is required to actively balance the quantity of their work with an acceptance level of quality while ensuring compliance.
• The amount of time noted as time spent for each responsibility is provided as a guideline and will vary dependent on actual responsibility required and associated with projects.

Key Requirements:

• (Minimum) Bachelor of Science Degree in a relevant discipline (eg. Biology, Microbiology, Biochemistry).
• (Preferred) Advanced Science Degree in a relevant discipline.
• 6-10 years related experience in the Pharmaceutical Industry
• Strong technical background, expertise in vaccines or biologics with demonstrated knowledge of quality practices
• Strong skills in decision making, problem solving and critical thinking
• Strong written and communication skills are critical to ensure teams are guided through cGMP (Quality System) requirements
• Excellent knowledge of the GMPs for US, Canada and Europe

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
#GD-SP #LI-SP 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.