Reference No. R2782172 

Position Title: Quality Compliance Management

Department: Facilities and Utilities

Location: Toronto, Ontario

Duration: 1 year contract

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 B100 Maintenance Compliance Manager will lead deviation investigations; ensure B100 Maintenance compliance and the execution of continuous improvement initiatives as a result of deviation investigations within the B100 Maintenance department.

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?

Main Responsibilities:

Responsible for all significant and non-significant deviations associated with B100 Maintenance Department (60%).

Determine the scope of the investigation by collaborating with Quality Operations (QO), Manufacturing and Subject Matter Experts (SME) as appropriate in real time on the shop floor.

Lead and develop an investigation strategy in collaboration with Manufacturing, Quality Operations, and SMEs.

Perform Root Cause Analysis by conducting Shop Floor Production Walkthrough (GEMBA), select appropriate analytical tools, collect and analyze data to determine the true root cause.

Identify expertise required for the investigation (MTech, Technical Services, QC, QOVS, QOSA, etc.).

Identify, co-ordinate and manage contributions from other departments.

Participate in Autonomous Production Team (APT) support team meetings for planning and execution of investigations.

Review and provide guidance on reports prepared by technical staff.

Prepare manufacturing investigations to support other functional areas as requested.

Write and manage associated documentation, actions, and timelines

Responsible to ensure that investigation reports and/or manufacturing investigation reports are clear, concise, and comprehensive.

Manage the deviation review process and ensure deviation investigations are closed according to targeted timelines.

Ensure actions are assigned to the appropriate individuals and completed to meet timelines.

Develop and execute appropriate corrective and preventive actions (CAPA). (10%)

In collaboration with platform management and other stakeholders, develop appropriate CAPAs with a clearly defined scope to address the root cause.

Initiate CAPAs in the Quality System as required.

Update GMP documents arising from CAPAs.

Manage CAPAs assigned to B100 Maintenance Department to ensure completion by the targeted timelines.

Review CAPAs associated with recurring issues and escalate any issues to Platform Leaders.

Work with Platform Leaders to identify and develop process improvements to remediate risks.

Develop Investigation cases to present at Governance boards. (10%)

Work with SMEs and appropriate QO experts; develop assessment of risk to product, process, and other stages.

Utilize the Deviation Review Board Governance as required.

Prepare for Regulatory inspections by drafting investigation briefing packages / hot topics as applicable.

Provide support to the area manager during Regulatory inspections and other audits.

Responsible for Shop Floor Compliance within the Platform (10%)

Prepare documents required for Maintenance planned and unplanned events and area restoration for Quality release of classified environments.

Create and manage change request to implement changes within GMP scope to ensure timely closure.

Track and develop action plan to address gaps, as required.

Continuous Improvement and GMP Documentation Review within the Platform (10%)

Lead continuous improvement initiatives as outputs of investigations and provide compliance direction and monitoring as related to Shop Floor operations.

Participate in special projects for process improvement projects to meet GMP requirements and address inspection observations.

Provides metrics and other reports as required.

Support GMP Documentation review as required.

Scope and dimensions

Breadth of responsibility (global/regional/country/site): Reporting to the Deputy Director, B100 APU Maintenance Lead, the B100 Maintenance Compliance Manager will be a member of the B100 Maintenance Team.

Key dimensions:

The B100 Maintenance Compliance Manager would have no direct reports but would interface and coordinate with all other members of the B100 Maintenance team and other cross-functioning departments.

Freedom to act, level of autonomy:

This position is expected to facilitate and drive timely and sound decisions while strongly collaborating within a team environment.  The ability to act without close supervision, pro-activity, and competent decision making is a key expectation.

About You

Education and experience

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

Minimum university degree in Microbiology, Biochemistry, Engineering, Biotechnology or Related Science or higher-level Education.

Minimum of (4) years relevant experience in Commercial Manufacturing, Manufacturing Technology, Quality Operations or similar role. 

Key technical competencies and soft skills:

High level of knowledge of cGMPs in pharmaceuticals/biological manufacturing environment

Experience in regulatory inspections

Good problem-solving skills

Excellent communication and organization skills.

Excellent technical writing skills

Six-sigma or other root cause training and experience

Knowledge and experience with multiple software programs such as SAP, Trackwise, Word, Outlook, Visio and PowerPoint

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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Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!