Program Manager, SA Validation, OQSA - Vaccine

Job description

Reference No. R2582697

Position Title: Program Manager, SA Validation, OQSA

Department: QOSA Site Support

Location: Sanofi Pasteur Limited, Toronto, Ontario

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.

Mission:

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, Flow Diagrams, Gowning) Program Manager, Environmental Monitoring and Clean Utilities Program Manager, SA Validation (i.e. APSS, ISO, EM-Re-validation)

The Program Manager:

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will be accountable for managing the program for which they have oversight by: ensuring that the program is aligned with regulatory requirements, global policies and defined within robust policies and procedures; providing technical support to the program for which they have oversight.

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will be responsible for ensuring Technical Managers supporting the program in the other OQSA APUs are aligned.

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will provide support to the APU for implementation and/or execution of OQSA initiatives.

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Support other OQSA program platforms as required.

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will report 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.

Key Accountabilities:

Manage one of three QOSA Programs for the Toronto Site (65%):

1. Contamination Control Program

Maintain the validated state of manufacturing and testing environments through the oversight and ownership of:

· 
Site and Area specific Cleaning and Disinfection programs

· 
Site and Area specific Personnel Gowning programs

· 
Site and Area specific Equipment, personnel and material flows

Manage assessments of CCRs and approval of CAPAs – including the closure of completed action items for CCRs and CAPAs.

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

Review and approve architectural and flow drawings for production facilities.

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

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

Develop/maintain key performance indicators for program.

Provide training to end users on program level changes.

2. 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 Senior Technologists / Coordinators, ensuring that shop-floor programs are maintained in a state of compliance.

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

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

· 
Manage assessments of CCRs and approval of CAPAs – including the closure of completed action items for CCRs and CAPAs.

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

· 
Develop/maintain key performance indicators for program.

· 
Provide training to end users on program level changes.

3. Sterility Assurance Validation Program:

· 
Ensure that environmental validation, requalification, and APSS practices are in alignment with regulatory requirements and corporate policies.   

· 
Manage assessments of CCRs and approval of CAPAs – including the closure of completed action items for CCRs and CAPAs.

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

· 
Support review and approval of environmental validation, ISO Requalification, and APSS protocols and reports.

· 
Assess and design robust aseptic process simulation studies for manufacturing processes and demonstrate worst case scenarios to support the process validation/requalification requirements.

· 
Perform quality oversight during execution of the aseptic processing simulations and technical reviews of executed protocols to assure all requirements are executed in accordance with company standards and regulatory requirements.

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

· 
Develop, review and/or approve sterility assurance validation/requalification related documents and HACCP reports (include but are not limited to SOPs, records, protocols and reports).

· 
Develop/maintain key performance indicators for program.

· 
Provide training to end users on program level changes.

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

Support any sterility assurance related inspection readiness activities:

· 
Will be the SME for the Program that they lead

· 
Prepare inspection readiness packages

· 
Defend the sterility assurance program (for which they have oversight) during internal and external inspections, when required

Support continuous improvement to the sterility assurance programs:

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Participate in various assigned sterility assurance related projects.

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

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Design and/or conduct experimental / qualification studies when required.

Education and Experience :

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

· 
3-5 years of related industry experience

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

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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)

Key technical competencies and soft skills:

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

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

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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.

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

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

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

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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  

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.