Full-Time

Principal Manufacturing Compliance Engineer

Updated on 1/20/2025

Sanofi

Sanofi

10,001+ employees

Develops pharmaceuticals and life-saving vaccines

Biotechnology
Healthcare

Senior, Expert

Framingham, MA, USA

Onsite presence required.

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Required Skills
SAP Products

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Degree
Experience
Requirements
  • 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.
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 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: Participate in timely completion of investigation, deviations and CAPA 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.
Desired Qualifications
  • Bachelor’s degree in Biology, Chemistry, Biochemistry, Chemical Engineering.
  • 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

Sanofi provides healthcare solutions through its pharmaceutical and biotechnology products, focusing on treatments and vaccines for various medical conditions. The company conducts extensive research and development to create new therapies and improve existing ones, particularly in areas like immunology, oncology, and rare diseases. Sanofi differentiates itself from competitors by its strong commitment to scientific innovation and a diverse product portfolio that includes prescription medicines and vaccines. Its goal is to enhance health outcomes and improve the quality of life for people globally by delivering effective and safe healthcare solutions.

Company Stage

IPO

Total Funding

$2B

Headquarters

Paris, France

Founded

1973

Simplify Jobs

Simplify's Take

What believers are saying

  • FDA Breakthrough Therapy designation for tolebrutinib boosts Sanofi's neurology leadership.
  • Sanofi's Muse AI tool accelerates patient recruitment, reducing clinical trial timelines.
  • Investment in Zucara Therapeutics strengthens Sanofi's diabetes portfolio with innovative treatments.

What critics are saying

  • Regulatory delays in Japan and China for Sarclisa could impact revenue projections.
  • Liver enzyme elevations in tolebrutinib trials may lead to regulatory scrutiny.
  • Reliance on strategic partnerships poses risks if expected results are not achieved.

What makes Sanofi unique

  • Sanofi's Sarclisa is the first anti-CD38 therapy combined with VRd in the EU.
  • The Care4Rare program focuses on lysosomal storage diseases, offering unique patient solutions.
  • Sanofi's MyWay app enhances patient engagement and medication adherence through digital health.

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Benefits

Health Insurance

Professional Development Budget

Parental Leave