Sanofi · 1 day ago
Compliance Specialist
Framingham, MA
Full-time
Onsite
Entry, Mid Level
2+ years expSanofi is a leading healthcare company that delivers billions of healthcare solutions annually. The Compliance Specialist will utilize their expertise in compliance and GXP manufacturing processes to manage investigations and improvement initiatives within Engineering & Maintenance operations, ensuring compliance across various GMP activities.
Health CareLife SciencePharmaceuticalTherapeutics
Responsibilities
Practices and promotes safe work habits and adheres to Sanofi’s safety procedures and guidelines
Manages cross functional team to drive complex investigation close outs, determine root cause and implement appropriate Corrective and Preventative Action
Utilizes process knowledge and investigation skill sets to identify and resolve issues, improve process operations and affect positive change
Leads cross-functional continuous improvement initiatives with Engineering, Validation, Quality Assurance, Quality Control, Facilities, Metrology, and Manufacturing Technical Services
Works independently with minimal supervision and direction
Participates in determining objectives of assignment
Performs work that consistently requires independent decision making and the exercise of independent judgement and discretion
Effectively utilizes Microsoft office applications
Creates and presents trending and metrics reports
Understands concepts and applications of specialized or functional area, uses independent thought, analytical ability to achieve objectives that can impact the performance of standard resources that have been allocated through a plan or a budget
Compiles facts and diagnostics from a broad variety of sources (other functions/ internal stakeholders, customers, suppliers, regulators ...) to monitor the level of satisfaction or compliance associated with the delivery of products or services
Coordinates with others via teamwork and may provide technical or behavioral expertise and guidance to deliver results
Awareness of objectives of other functions and reacts quickly to recommend and promote efficient solutions or alternatives of complex issues
Qualification
Required
Bachelor's degree in Sciences, Technical, Engineering, Biology, Chemistry, Biochemistry, Chemical Engineering or related fields with 2 years in a cGXP manufacturing environment
OR Advanced degree in Sciences, Technical, Engineering, Biology, Chemistry, Biochemistry, Chemical Engineering or related fields with 3 years in a cGXP manufacturing environment
Experience with deviation management systems (e.g. Trackwise, Phenix)
Practices and promotes safe work habits and adheres to Sanofi's safety procedures and guidelines
Manages cross functional team to drive complex investigation close outs, determine root cause and implement appropriate Corrective and Preventative Action
Utilizes process knowledge and investigation skill sets to identify and resolve issues, improve process operations and affect positive change
Leads cross-functional continuous improvement initiatives with Engineering, Validation, Quality Assurance, Quality Control, Facilities, Metrology, and Manufacturing Technical Services
Works independently with minimal supervision and direction
Participates in determining objectives of assignment
Performs work that consistently requires independent decision making and the exercise of independent judgement and discretion
Effectively utilizes Microsoft office applications
Creates and presents trending and metrics reports
Understands concepts and applications of specialized or functional area, uses independent thought, analytical ability to achieve objectives that can impact the performance of standard resources that have been allocated through a plan or a budget
Compiles facts and diagnostics from a broad variety of sources (other functions/ internal stakeholders, customers, suppliers, regulators ...) to monitor the level of satisfaction or compliance associated with the delivery of products or services
Coordinates with others via teamwork and may provide technical or behavioral expertise and guidance to deliver results
Awareness of objectives of other functions and reacts quickly to recommend and promote efficient solutions or alternatives of complex issues
Preferred
Knowledge and understanding of Manufacturing and GXP regulations and guidance
Excellent critical thinking and technical writing skills
Proficient with change control requests, CAPAs and deviation quality systems
Experience leading cross functional teams and facilitating team meetings with ability to influence in a cross-functional environment
Proficient in balancing the speed of delivering work with quality and shows commitment to make improvements in both aspects
Effectively tracks tasks related to deviations, CAPAs, or CCRs to ensure on-time adherence and delivers results on time
Ability to work independently with minimal supervision to problem solve efficiently
Experience with project management, troubleshooting, investigation and root cause analysis in a GXP environment
Operations experience in one or more of the following areas: Quality Assurance, Quality Control, Manufacturing Technical Support, Facilities Engineering, or Automation
Ability to gown and gain entry to manufacturing areas
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
Company data provided by crunchbase