Production Compliance Manager - Vaccines

Reference No. R2735533

Position Title: Production Compliance Manager - Vaccines

Duration: Fixed-Term - Contract End Date: April 4, 2025

Department: DTPPD Ffast

Location: Toronto, Ontario

Sanofi Vaccines

Sanofi's global vaccines business unit partners with the public health, medical and scientific communities to improve access to life-protecting vaccines and increase vaccination coverage, while striving to develop new and improved vaccines to enhance health and well-being.

At Sanofi, we chase the miracles of science to improve people’s lives.  We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.

Position Summary:

The Production Compliance Manager is a detail-oriented and results-driven individual with a strong understanding of biologics manufacturing, cGMPs, root cause analysis and possesses exceptional technical writing skills. The incumbent is responsible for leading Deviation Investigations, ensuring Shop Floor compliance and execution of continuous improvement initiatives as a result of Deviation Investigations within the DT/PPD Manufacturing department.

Key Responsibilities:

Responsible for all critical, major and minor deviations associated with the Platform (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 appropriate corrective and preventive actions. (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.

• Support manufacturing staff on updating GMP documents arising from CAPAs.

• 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.

• Present and defend investigations and provide support to the area manager for process / procedure topics during Regulatory inspections and other audits.

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

• Lead and manage Data Integrity activities, initiatives and continuous improvements within the Platform in collaboration with APT Support teams and QOVS.

• Perform Shop Floor Production Walkthroughs (GEMBA) to identify compliance gaps.

• 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 production process improvement projects to meet GMP requirements and address inspection observations.

• Provides metrics and other reports as required.

• Support GMP Documentation review (BPRs, logbooks, etc.) as required.

• Be a subject matter expert on process flow and area procedures.

• Act as a backup to the shift manager for vacation coverage and other.

HSE Requirement/Statement:

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

Context of the job/Major challenges:

• Collaborate with Quality Operations (QO), Manufacturing and Subject Matter Experts (SME) to ensure deviation investigations are closed according to targeted timelines.

Physical working conditions:

• Production area environment. Continued presence on shop floor.

• Office area environment

Dimensions/Scope:

• Individual Contributor

Key Requirements:

• Minimum BSc. in Microbiology, Biochemistry, Engineering, Biotechnology or Related Science or higher Level Education.

• A minimum of four (4) years of previous relevant experience in Commercial Manufacturing, Manufacturing Technology, Quality Operations or similar role.

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

• Experience in regulatory inspections.

• Good problem solving skills.

• Must possess 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.

• Stretch – try new things, take calculated risks, look for ways to apply learning

• Take action – prioritize, focus on what is important, hold self and others accountable.

• Act for patients and customers – ensure actions are in support of Sanofi strategy, look at what is best for customers.

• Think Sanofi first – share information openly, think of what is best outside the team & function, help colleagues across the organization.

Pursue Progress

Discover Extraordinary

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.

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

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.

Follow Sanofi on Twitter: @SanofiCanada  and on LinkedIn: https://www.linkedin.com/company/sanofi

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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.