Compliance Manager (Upstream) - Vaccines

Reference No. R2767851 ​

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. Your job, as a Production Compliance Manager within our global vaccines business will be to drive continuous improvement in Influenza drug substance manufacturing by leading deviation investigations and using your findings to deliver positive change.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main Responsibilities:

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/Non-Conformance Investigations, executing continuous improvement initiatives,leading Change Controls on behalf of the Flu Operations team, and ensuring Shop Floor compliance.

Responsible for critical, major, and minor deviations associated with the Platform:

• Focusing on the Upstream operations (Eggs receiving, Inoculation, Incubation and Harvest), 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 (MSAT, Process Engineering, C&Q, Technical Services, QC, QOVS, QOSA, etc.), co-ordinate and manage contributions from other departments.

• 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.

B200 Flu Project Support:

• Support investigation of non-conformances during project phase, identify root cause, and work with the team to identify and implement appropriate corrective actions.

• Support shop-floor execution of Engineering/Development/Process Performance Qualification (PPQ) and Environmental Monitoring Process Qualification (EMPQ) protocols, as needed.

Change Control Lead  

• Initiate and manage change control requests affecting the B200 Flu Manufacturing department.

• Collaborate with assessors for evaluation of changes.

• Ensure timely closure of change controls.    

• Track and monitor change control progress.

Develop Appropriate Corrective and Preventative Actions (CAPAs):

• 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:

• 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:

• 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.

• Act as Administrator for standalone equipment and ensure compliance with regular user access reviews, as well as audit trail backup and storage.

Continuous Improvement and GMP Documentation Review within the Platform:

• 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 improvements to meet GMP requirements and/or address inspection observations.

• Provides metrics and other reports as required.

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

About You

Education and Experience:

• Minimum B.Sc. in Microbiology, Biochemistry, Engineering, Biotechnology or Related Science

• A minimum of two (2) years (four years preferred) 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 an asset

• Good problem-solving skills

• Must possess excellent communication, technical writing, and organization skills.

• Six-sigma or other root cause training and experience an asset

• Knowledge and experience with multiple software programs such as 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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