Production Compliance Manager - Vaccine

Reference No. R2778383

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 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.

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:

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

About You

REQUIREMENTS

Education/Certifications:

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

Experience:

• 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

Competencies:

• 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

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