Principal Compliance Engineer
Sanofi
June 25, 2026
Remote friendly (Waltham, MA)
United States
$122,250 - $176,583.33 USD yearly
Corporate Functions
Main Responsibilities
- Lead and support GMP investigations for clinical manufacturing deviations; apply root cause analysis and cross-functional collaboration to ensure timely batch release decisions.
- Serve as a process SME for the GCM group (process-related quality events, manufacturing troubleshooting, urgent production issues).
- Conduct on-site investigations (gemba) with internal/external manufacturing teams to resolve quality issues and identify process improvements.
- Perform product impact assessments for deviations/quality events to support batch disposition using science-based decision making.
- Manage investigation documentation and closure in internal QMS systems to ensure regulatory compliance and traceability.
- Collaborate with raw materials team and external suppliers (raw materials, single-use consumables) to investigate quality issues and propose supplier improvements.
- Participate in Risk Management teams.
Continuous Improvements and Lean Initiatives
- Partner with Manufacturing, Quality, Process Development, and Analytical Development to recommend and implement CAPAs.
- Implement Lean and 5S initiatives to improve operational efficiency; assess and enhance lean/5S/SMS knowledge.
- Evaluate existing lean systems and suggest mitigation strategies.
- Support improvements in ways of working during investigations and quality event documentation.
- Collaborate with Process Development and process trending leads to analyze in-process and final GMP batch data.
- Participate in Data Insights to evaluate data trends.
GCM Performance Tracking and Evaluation
- Contribute to performance tracking tools for GCM investigations and quality event trends.
- Create and present quality event trending/metrics reports with continuous improvement suggestions.
Qualifications
- BS in Engineering/Life Sciences (or related) OR MS in Engineering.
- 10+ years industry experience with at least 5 years in GMP processes (or related/equivalent).
- Excellent communication; Microsoft Office experience; strong documentation and attention to detail.
Technical Skills
- Strong GMP investigation experience; science-based risk assessments and impact evaluations.
- Root cause analysis methods (e.g., Fishbone, 5-Why, Fault Tree Analysis).
- Knowledge/experience with manufacturing process/technical/process development/technology transfer; focus on mRNA, biologics, or ATMPs (preferred).
- Deviation management and CAPA implementation; quality management/quality event management familiarity; ability to analyze product/process manufacturing data.
Benefits/Instructions
- At least 14 weeks’ gender-neutral parental leave; company rewards package (details not otherwise provided).
- Lead and support GMP investigations for clinical manufacturing deviations; apply root cause analysis and cross-functional collaboration to ensure timely batch release decisions.
- Serve as a process SME for the GCM group (process-related quality events, manufacturing troubleshooting, urgent production issues).
- Conduct on-site investigations (gemba) with internal/external manufacturing teams to resolve quality issues and identify process improvements.
- Perform product impact assessments for deviations/quality events to support batch disposition using science-based decision making.
- Manage investigation documentation and closure in internal QMS systems to ensure regulatory compliance and traceability.
- Collaborate with raw materials team and external suppliers (raw materials, single-use consumables) to investigate quality issues and propose supplier improvements.
- Participate in Risk Management teams.
Continuous Improvements and Lean Initiatives
- Partner with Manufacturing, Quality, Process Development, and Analytical Development to recommend and implement CAPAs.
- Implement Lean and 5S initiatives to improve operational efficiency; assess and enhance lean/5S/SMS knowledge.
- Evaluate existing lean systems and suggest mitigation strategies.
- Support improvements in ways of working during investigations and quality event documentation.
- Collaborate with Process Development and process trending leads to analyze in-process and final GMP batch data.
- Participate in Data Insights to evaluate data trends.
GCM Performance Tracking and Evaluation
- Contribute to performance tracking tools for GCM investigations and quality event trends.
- Create and present quality event trending/metrics reports with continuous improvement suggestions.
Qualifications
- BS in Engineering/Life Sciences (or related) OR MS in Engineering.
- 10+ years industry experience with at least 5 years in GMP processes (or related/equivalent).
- Excellent communication; Microsoft Office experience; strong documentation and attention to detail.
Technical Skills
- Strong GMP investigation experience; science-based risk assessments and impact evaluations.
- Root cause analysis methods (e.g., Fishbone, 5-Why, Fault Tree Analysis).
- Knowledge/experience with manufacturing process/technical/process development/technology transfer; focus on mRNA, biologics, or ATMPs (preferred).
- Deviation management and CAPA implementation; quality management/quality event management familiarity; ability to analyze product/process manufacturing data.
Benefits/Instructions
- At least 14 weeks’ gender-neutral parental leave; company rewards package (details not otherwise provided).