Sanofi · 10 hours ago
Compliance Lead
Framingham, MA
Full-time
Onsite
Senior Level
$122K/yr - $177K/yr
5+ years expSanofi is a global biopharma company committed to improving people's lives through innovative treatments. The Compliance Lead will manage compliance efforts for the Engineering and Maintenance department, ensuring adherence to safety and quality standards while leading a team to achieve operational goals.
Health CareLife SciencePharmaceuticalTherapeutics
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
Qualification
Required
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
Preferred
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
Benefits
High-quality healthcare
Prevention and wellness programs
At least 14 weeks’ gender-neutral parental leave
Company
Sanofi
Sanofi is a global biopharma company focused on prescription drugs, vaccines, and treatments for chronic, rare, and infectious diseases.
10001+ employees
H1B Sponsorship
Sanofi has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (101)
2024 (68)
2023 (59)
2022 (78)
2021 (38)
2020 (38)
Funding
Current Stage
Public CompanyTotal Funding
$6.97BKey Investors
Blackstone Life SciencesEvotec
2025-10-28Post Ipo Debt· $3B
2025-06-17Post Ipo Debt· $1.74B
2025-03-05Post Ipo Debt· $1.59B
Leadership Team
Paul Hudson
Chief Executive Officer
Francois-Xavier Roger
Chief Financial Officer
Recent News
MarketScreener
2025-12-31
2025-12-30
Company data provided by crunchbase