Job Description

Reference No. R2663669

Position Title: Program Manager Contamination Control - Vaccines

Department: Sterility Assurance Programs & Site Support

Location: 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 OQSA Program Manager is responsible for ensuring the Program they lead is managed consistently within all APU functions across the Site.

The OQSA Program Manager has primary responsibility for one of the following three programs:

Program Manager, Contamination Control (i.e. Cleaning and Disinfection, Material, Equipment and Personnel Flows, Gowning) Program Manager, Environmental Monitoring and Clean Utilities Program Manager, SA Validation (i.e. APSS Validation/Re-Qualification, ISO, EM-Validation /Re-validation)

The Program Manager:

Ensuring that the program is aligned with regulatory requirements, global policies and defined within robust site policies and procedures

providing technical support to the program for which they have oversight.

Provide support to the APU for implementation and/or execution of OQSA initiatives Support other OQSA program platforms as required. Reports directly to the Deputy Director of Site Support.

This position requires on-going collaboration with various technical and quality professionals from Quality and other key Departments (e.g. Operational Quality, Technical Services, Production, Manufacturing Technology and ITS) at the site and globally.

The OQSA Program Manager is responsible for ensuring the Program they lead is managed consistently within all APU functions across the Site.

The OQSA Program Manager has primary responsibility for one of the following three programs:

Program Manager, Contamination Control (i.e. Cleaning and Disinfection, Material, Equipment and Personnel Flows, Gowning).

Program Manager, Environmental Monitoring and Clean Utilities.

Program Manager, SA Validation (i.e. APSS Validation/Re-Qualification, ISO, EM-Validation /Re-validation).

The Program Manager is accountable for:

ensuring that the program is aligned with regulatory requirements, global policies and defined within robust site policies and procedures

providing technical support to the program for which they have oversight

Provide support to the APU for implementation and/or execution of OQSA initiatives Support other OQSA program platforms as required. Reports directly to the Deputy Director of Site Support

This position requires on-going collaboration with various technical and quality professionals from Quality and other key Departments (e.g. Operational Quality, Technical Services, Production, Manufacturing Technology and ITS) at the site and globally.

Key Responsibilities:

Manage one of three QOSA Programs for the Toronto Site .

Manage assessments/approvals of site wide CCRs and CAPAs

Provide Quality direction to assure the sterility assurance practices for manufacturing are in a state of control

Collaborate and liaise with APU SA Support to ensure alignment of program changes

Participate and support execution of Site Quality Plan initiatives. Develop/maintain key performance indicators for program (i.e. EAC, SQC, SQP)

Develop, review and/or approve training modules, SOPs and technical documents

Provide training to end users on program level changes.

Program specific accountabilities listed below:

Contamination Control Program

Oversight and ownership of:

Site Cleaning and Disinfection programs.

Site Personnel Gowning programs.

Site Equipment, personnel and material flows.

Review and approve architectural and flow drawings for production facilities, as required.

Oversee planning/execution/approval of Cleaning & Disinfection studies.

Environmental Monitoring & Clean Utilities Program

Support the Environmental Monitoring and Clean utilities program to ensure that routine sampling and testing is aligned with regulatory, global and site requirements.

Manage and provide coaching/guidance to the OQSA Coordinators, ensuring that shop-floor programs are maintained in a state of compliance.

Provide technical support / direction to non-conformance investigations and related assessments.

Manage the Environmental Monitoring & Clean Utility trending programs, ensuring that routine reports are completed in a timely manner.

Sterility Assurance Validation Program

Ensure that APSS Validation/Re/Qualification, environmental/ISO Certification validation/re-validation are in alignment with regulatory requirements and corporate policies.

Oversee creation and management of site scheduling protocols for SA Validations.

Provide leadership and technical support to all APUs for implementation and/or execution of OQSA initiatives as required:

Responsible for sterility assurance oversight and review of aseptic techniques and operator behaviors for smoke studies of aseptic processes.

Support any sterility assurance related inspection readiness activities

SME for the Program during internal and external inspections

Prepare inspection readiness packages

Support continuous improvement to the sterility assurance programs.

Participate in sterility assurance related projects.

Conduct technical / quality assessment for process improvement or bringing in new.

Design and/or conduct qualification studies/ risk assessments.

Scope/dimensions:

Breadth of responsibility (global/regional/country/site):

Scope includes IA manufacturing and R&D support at the Toronto Site. Interaction with other sites globally as required for the purpose of collaboration and benchmarking.

Key dimensions: headcount (direct and indirect) budget, doses, Capex... - Key indicators on which the job holder will be evaluated (WHAT in 9box):

Sterility assurance compliance for the assigned program:

Contamination Control Program.

Environmental Monitoring & Clean Utilities Program.

Sterility Assurance Validation Programs.

Freedom to act, level of autonomy:

Position has a high degree of autonomy and is expected to make decisions and interpretations within broadly defined requirements.

Key Requirements:

Minimum B. Sc in Biology / Microbiology / Applied Pharmaceutical Sciences, Engineering.

5-7 years of related industry experience.

Experience in working in the laboratory setting, validation, quality design, and/or sterile manufacturing.

With mechanical aptitude and preferably experience in reviewing facility and utility related drawings.

Participation in Industrial Committees (e.g. PDA, ISPE, ISO).

Proficient in experimental design, computing and the use of statistical tools (e.g. MS-Word, Excel, -Power Point, -Access, -Visio, and JMP, BlueCielo).

The incumbent must stay current with changing regulatory environment, new technologies, and qualification approaches in the field of sterility assurance.

The incumbent must be detail oriented, proficient in performing or familiar with risk assessment, gap and statistic control analysis.

The incumbent must possess excellent interpersonal and communicative (both verbal and writing) skills in order to collaborate effectively and transversally with key stakeholders at the site.

The incumbent must be adept with problem solving, and finding ways towards resolution.

The incumbent must have excellent presentation skills as part of training and qualifying site personnel on sterility assurance related policies and procedures.

The incumbent must work within the policies, procedures and regulations as required by the Company and under the Occupational Health and Safety Act.

Relevant immunization and medical clearance are required.

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.