Sanofi · 1 day ago
Principal Manufacturing Compliance Engineer
Framingham, MA
Full-time
Hybrid
Senior Level, Lead/Staff
$113K/yr - $164K/yr
3+ years expSanofi is a global biopharma company committed to improving lives through innovative treatments. The Principal Manufacturing Compliance Engineer will manage investigations and compliance within manufacturing operations, ensuring adherence to quality and regulatory standards while driving continuous improvement initiatives.
Health CareLife SciencePharmaceuticalTherapeutics
Responsibilities
Practice and promotes safe work habits and adheres to Sanofi’s safety procedures and guidelines
Lead and perform investigations, CAPAs and Change Controls (CCRs)for on-time closure and supporting Annual Product Reviews
Provide guidance and direction to team to drive complex investigation close outs, determine root cause and implement appropriate Corrective and Preventative Action
Utilize manufacturing process knowledge and investigation skill sets to identify and resolve manufacturing issues, improve process operations, and affect positive change
Represent Manufacturing Compliance Engineer team on cross-functional teams involved in the design and implementation of new or updated quality systems in accordance with the corporate standards, regulatory standards, cGMP, and industry standards
Actively participate and provide input and feedback to cross functional teams to ensure alignment on investigations and identified corrective and preventative actions
Escalate to management when investigations pose risk shipment or release and impact to department and site metrics
Maintain and report applicable department or organizational metrics
Routinely perform trend and statistical analysis as required to identify continuous improvement opportunities within manufacturing functional groups
Work to develop strategy and action plans for improving the system where opportunities are identified
Lead and actively participate in cross-functional continuous improvement projects with Manufacturing, Engineering, Validation, Quality Assurance, Quality Control, Facilities, Metrology, and Manufacturing Technical Services
Recognize and act on potential compliance issues and opportunities for process changes/improvement
Provide front room support during regulatory inspections
Represent investigation team during internal and external GxP audits
Partner with cross functional teams and team members, direct and indirect management chain to ensure the following: Ø Participate in timely completion of investigation, deviations and CAPA Ø Facilitation, Collaboration, completion, and active follow-up
Support investigation team to ensure site Key Performance Indicators (KPIs) are consistently met
Use experience and knowledge of manufacturing functional areas to propose continuous improvements to deliver efficiency gains
Assess customer needs and provides effective solutions through regular analysis of data and information reported from a broad variety of sources
Routinely assess progress made against Key Performance indicators to reach individual and team goals
Sensitive to the broader work environment and fosters relationships with partners, experts from other functions and customers in order to achieve tactical objectives
Monitor Quality Systems (e.g., investigations and CAPAs) activities to ensure compliance with company and regulatory standards
Assist with Quality Management Review (QMR)/Quality Council
Support Corporate Compliance initiatives
Qualification
Required
Bachelor's degree in Sciences, Technical, Engineering or Advanced degree with 8 years in a cGXP manufacturing environment or a Master's degree in Sciences, Technical, Engineering or Advanced degree and 3 years of experience in cGXP manufacturing environment
Experience in troubleshooting, investigation, and root cause analysis in a cGMP environment
Proficiency with critical thinking and technical writing
Thorough knowledge and understanding of the technical and commercial aspects of pharmaceutical API products, Current Good Manufacturing Practices {part of GxP}, validation principles, and applicable regulations
Extensive experience with Quality Management Systems
Ability to learn and operate various enterprise systems including LIMS, SAP, OSI/PI, EMS, BMS, is required
Regardless of format, able to carry all technical communications which will allow the end-user, specifically QA personnel and regulatory inspectors, to arrive at the intended conclusions
Knowledge of GXP regulations and guidance
Ability to effectively coach and train employees
Demonstrate high-level of communication for cross-functionally and across levels, including timely identification of potential sources of conflict and resolve independently or escalate to stakeholders promptly
Excellent verbal and written communication skills, with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups
Strong ability to balances the speed of delivering work with quality and shows commitment to make improvements in both aspects
Demonstrate a high degree of engagement and involvement in all job-related activities. Catalyst for selecting methods, techniques and evaluation criteria for obtaining results. Mentor junior members of team on technical topics. May potentially be a Qualified Trainer on investigation process
Preferred
Operations experience in one or more of the following areas: Quality Assurance, Quality Control, Manufacturing Technical Support, Facilities Engineering, or Automation
Keeps tasks (deviations, CAPA, or CCR) on schedule, tracks them carefully, and delivers results on time; seeks assistance to solve a problem quickly to adhere to on-time delivery
Experience with project management
Experience in supervisory teams
Ability to lead staff in absence to people manager
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
2026-01-12
Company data provided by crunchbase