Principal Compliance Engineer

Sanofi•Waltham, MA

7d•Onsite

About The Position

As Principal Compliance Engineer within our R&D team, you will play a key role in ensuring the timely and thorough execution of investigations to ensure clinical batches are best positioned for release. This position is critical to maintaining the highest standards of quality and compliance in our clinical manufacturing operations, directly supporting the development of life-changing medicines for patients worldwide. In this role, you will lead and contribute to cross-functional investigations, implement corrective and preventative actions (CAPAs) based on investigational conclusions, apply Lean methodologies to drive operational efficiency, and create and present quality event tracking to identify opportunities for continuous improvement in manufacturing processes. Your expertise will be essential in maintaining compliance standards while optimizing manufacturing operations to support Sanofi's mission of bringing innovative treatments to patients faster and more efficiently. Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. 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

BS in Engineering, Life sciences or related disciplines; OR MS in Engineering.
10+ years of industry experience with at least 5 years of experience in GMP processes or related/equivalent.
Excellent communication skills, with the ability to provide clear and concise guidance on technical tasks, scheduling challenges, and proposed solutions.
Experience with Microsoft office applications
Demonstrated ability to work on multiple projects effectively and maintain exceptional attention to detail.
Highly organized, with exceptional attention to detail and strong proficiency in documentation.
Demonstrated ability to facilitate project team meetings, enhance cross-functional communication, support decision making, influence outcomes, and ensure alignment among internal and external stakeholders.
Results-driven with a strong focus on achieving operational and organizational objectives.
Strong GMP investigation experience with experience in driving cross-functional team collaboration through complex manufacturing deviations and quality events
Demonstrated analytical and problem-solving skills with ability to perform science-based risk assessments and impact evaluations as it relates to GMP manufacturing
Expertise in root cause analysis methodologies (e.g., Fishbone, 5-Why, Fault Tree Analysis) and when to appropriately apply methods
Demonstrated knowledge/understanding of manufacturing process or experience in technical/process development, process/technology transfer, and GMP manufacturing, with a focus on mRNA, biologics or ATMPs (expertise in any of these areas is highly valued).
Experience with deviation management and implementing corrective and preventative action (CAPA)
Strong familiarity with quality management systems and quality event management processes
Understanding of product and process manufacturing data and how to perform analysis to support root cause determination

Nice To Haves

expertise in mRNA, biologics or ATMPs is highly valued

Responsibilities

Lead and support GMP investigations for clinical manufacturing deviations with scientific rigor, utilizing root cause analysis methodologies and cross-functional collaboration to ensure timely batch release decisions
Serve as a process SME for the GCM group providing technical expertise on process related quality events, manufacturing troubleshooting, and urgent production issues
Conduct on-site investigations (gemba) with internal and external manufacturing teams to identify process improvements and resolve quality issues
Perform product impact assessments for deviations and quality events, applying science-based decision making allowing for batch disposition
Manage investigation documentation and closure within internal QMS systems, ensuring regulatory compliance and traceability
Collaborate with the internal raw materials team and external suppliers (raw materials, single-use consumables) to investigate quality issues and propose supplier improvements
Participate in Risk Management teams
Partner with Manufacturing, Quality, Process Development, Analytical Development, and other departments to recommend and implement CAPAs based off investigational conclusions
Assist in increasing operational efficiency through the implementation of Lean and 5S initiatives across manufacturing areas
Regularly assess and enhance lean/5S/SMS knowledge
Support efforts to evaluate the efficiency of the existing lean systems, suggesting mitigation strategies for issues identified
Participate in efforts to improve ways of working while conducting investigations and documenting quality events
Collaborate with the process development team to implement solutions to improve process efficiency and product quality.
Collaborate with Process Development process trending leads to analyze in-process and final GMP batch data to evaluate process efficiency
Participate in Data Insights team to evaluate data trends across the organization
Contribute to the design and implementation of performance tracking tools for GCM investigation and quality event trends
Create and present quality event trending and metrics reports with suggestions for continuous improvements