Compliance Specialist, Engineering

Job Title: Compliance Specialist

Location: Framingham, MA

Compliance Specialist uses expert knowledge of compliance and GXP manufacturing processes to manage investigation and improvement initiatives within Engineering & Maintenance operations.

Engineering & Maintenance Compliance Team is responsible for managing change controls, CAPAs and deviation intake and closure across GMP activities in the following areas – Metrology, Engineering, Facilities, Utilities, Validation, Automation and Capital Projects. The responsibilities of the team primarily extend to owning deviations relating to facilities, equipment and utilities and their associated systems. The Senior Compliance Specialist is responsible for developing programs and metrics to ensure all aspects of engineering and maintenance are compliant.

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

• 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.

• 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).

• 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…