Compliance Lead - Right First Time - GMP

Sanofi•Framingham, MA

43d•Onsite

About The Position

Join a global network that powers how Sanofi delivers - seamlessly, purposefully, and at scale. In Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster. The Compliance Engineer organization supports the Engineering and Maintenance (EM) department by performing investigations and supporting the completion of CAPAs and change controls at the Sanofi, Framingham manufacturing facilities. Responsible for managing a compliance EM department supporting and coordinating Compliance efforts for the EM Department consisting of Engineers and specialists. Supports manufacturing facilities and manages staff performance against department's operational goals. About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.

Requirements

Bachelor's degree in Engineering, Automation, Life Sciences, or related discipline - preferred. A combination of education and experience will be considered.
5+ years of experience using various Root Cause Analysis tools (5W2H, fishbone, DMAIC, GPS3) which achieves consistent RFT (Right First Time) performance and the ability to perform Deviation Investigations - required.
Experience leading direct reports or teams in a cGXP/cGMP environment - required.

Nice To Haves

Extended experience in EM and/or pharmaceutical manufacturing.
Experience leading EM teams to maintain adherence to a demanding schedule.
Experience working with cross-functional teams, including Quality, Manufacturing
Technical Support, Operations, and Validation.
Strong documentation practices including batch production records, SOPs, OJTs, and other controlled documents.
Familiarity with Deviation Management Systems.
Experienced in troubleshooting, investigation, root cause and risk analysis in a cGMP environment.
Experienced leading the implementation of improvements to technical and business processes.
Experienced in managing direct reports who have leadership responsibilities
(supervisors and managers).
Experienced in making tactical decisions on safety, process, scheduling

Responsibilities

Ensure safety of all EM areas and work practices in accordance with site Health, Safety and Environmental program.
Recruits and manages staff to execute department functions; ensure effective utilization of resources through consistent performance management, and rewards and recognition practices in area of responsibility.
Provides leadership, guidance, and direction to staff in alignment cGMP requirements, department goals and corporate quality standards.
Partners with the Manufacturing Scheduler to ensure on time closures of deviations that can impact shipment dates
Create and maintain tracking metrics for Deviation, CAPA, and CCRs to ensure visibility to open or overdue events.
Ensures that appropriate levels of trained resources are available to meet production schedules.
Proactively identifies, assesses, and mitigates operational and organizational risks, escalate key risks and issues to manufacturing senior management and cross-functional support teams.
Establishes key performance indications in alignment with department goals, maintain and report applicable area or organizational metrics.
Escalate key risks and issues to manufacturing senior management and cross-functional support teams
Partners with Safety to ensure department compliance with requirements from
Sanofi's Safety Program including Health and Safety regulations and OSHA
requirements.
Ensures staff has appropriate knowledge of department processes and procedures to perform job responsibilities.
Ensures EM documentation and EM records reflect practice, are
aligned to cGMPs and corporate standards.
Design of the department training plan and manages training plan execution.
Training materials are accurate and sufficiently detailed.
Timely completion of investigations and deviations and CAPAs.
Implementation of continuous improvement initiatives and changes controls as needed.
Utilizes quality metrics to measure, analyze, and improve team performance.
Timely review of quality deliverables and "right first time"
Ensures inspection readiness of assigned EM areas.
Provides EM approval of department documentation changes.
Participates in inspections conducted by external regulators
Identifies opportunities to improve EM processes and practices.
Partners with cross-functional groups to troubleshoot and drive resolution of operational issues and proactively drive continuous improvement projects to completion.
departmental projects and ensure appropriate controls, approvals, and validation requirements are implemented.
Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs

Benefits

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 and at least 14 weeks' gender-neutral parental leave.

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