Sterility Assurance Site Support Technical Manager.

Reference No. R2766426​

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. ​

The Sterility Assurance Site Support Technical Manager is responsible for end-to-end management of continuous improvement activities and providing quality oversight of Sterility Assurance / Contamination Control programs. The role will further support the overall Site Quality Plan, site integration of new facilities and site deployment of Global initiatives to ensure Sterility Assurance practices are appropriately aligned with regulatory requirements and defined within robust policies and procedures.

The incumbent is expected to work independently and with a high level of autonomy and authority for decision making and will have the ability to lead multiple projects. This position requires strong collaboration and communication with key stakeholders across the organization, including Manufacturing Technology, Engineering Technical Services, Validation Services, Product Quality, RA, Quality Control and Quality Systems.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Drive continuous improvement and innovation activities through participation in Sterility Assurance related projects

• Develop project scope and objectives, involving all relevant stakeholders (at site and globally) and ensuring technical feasibility.

• Drive change management and value realization activities across multiple projects that improve the level of efficiency and/or quality within the Site Quality Organization and overall business.

• Create and maintain comprehensive project documentation and perform risk management to minimize project risks.

• Provide technical guidance and direction throughout project lifecycle and conduct Sterility Assurance assessments where needed.

Provide oversight of the site contamination control program

• Manage assessments/approvals/training of site wide CCRs and CAPAs. Develop, review and/or approve training modules, SOPs and technical documents.

• Provide support through coaching and knowledge transfer to ensure that there is in-depth understanding of specific operations, that issues are identified and addressed and promotes the development and maturity of a Quality culture.

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

• Provide technical direction for site integration of new facilities and site deployment of Global initiatives.

• Provide training to end users on program level changes.

• Support other SA Program (SA Validation, Training, Environmental and Critical Utility Monitoring) as needed.

Inspection Readiness for Internal and External Audits

• Ensure alignment to Site Policies, Global Standards and new Regulatory requirement and participates in gap assessments and remediation.

• Actively contributes and prepares the area for inspections and participates in self-inspections / audits and responses as applicable.

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

• Scope includes M&S 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:

• Position liaises across all M&S departments and R&D

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.

Specific degree, duration of experience (Required to hold the job):

• Minimum Bachelor of Science degree specializing in Biology / Microbiology / Applied Pharmaceutical Sciences / Engineering with 5+ years of relevant experience in Quality Operations from a Pharmaceutical or Biologics Manufacturing facility.

• Demonstrated experience with Project Management. Project Management certification preferred.

Key technical competencies and soft skills

• 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.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs

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.​

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