Compliance Specialist
Sanofi
2 months ago
On-site
Framingham, MA
Corporate Functions
Main Responsibilities:
- Practices and promotes safe work habits; adheres to safety procedures and guidelines.
- Manages cross-functional team to drive complex investigation closeouts, determine root cause, and implement Corrective and Preventative Action.
- Uses process knowledge and investigation skills to identify/resolve issues, improve operations, and drive 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; participates in determining objectives of assignment.
- Performs work requiring independent decision-making and independent judgment/discretion.
- Effectively utilizes Microsoft Office applications.
- Creates and presents trending and metrics reports.
- Compiles facts/diagnostics from internal/external sources (e.g., stakeholders, customers, suppliers, regulators) to monitor compliance.
- Coordinates via teamwork; may provide technical/behavioral expertise and guidance.
Basic Qualifications:
- Bachelor’s degree in Sciences/Technical/Engineering or related field with 3 years in a cGXP manufacturing environment.
- OR advanced degree in the same fields with experience in a cGXP manufacturing environment.
Preferred Qualifications:
- Experience with deviation management systems (e.g., Trackwise, Phenix).
- Knowledge of Manufacturing and GXP regulations and guidance.
- Excellent critical thinking and technical writing; excellent written and oral English.
- Proficient with change control requests, CAPAs, and deviation quality systems.
- Experience leading cross-functional teams and facilitating meetings; ability to influence.
- Ability to balance speed and quality; tracks deviations/CAPAs/CCRs to meet timelines.
- Experience with project management, troubleshooting, investigation, and root cause analysis in a GXP environment.
- Operations experience in Quality Assurance, Quality Control, Manufacturing Technical Support, Facilities Engineering, and/or Automation.
- Ability to gown and gain entry to manufacturing areas.
- Practices and promotes safe work habits; adheres to safety procedures and guidelines.
- Manages cross-functional team to drive complex investigation closeouts, determine root cause, and implement Corrective and Preventative Action.
- Uses process knowledge and investigation skills to identify/resolve issues, improve operations, and drive 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; participates in determining objectives of assignment.
- Performs work requiring independent decision-making and independent judgment/discretion.
- Effectively utilizes Microsoft Office applications.
- Creates and presents trending and metrics reports.
- Compiles facts/diagnostics from internal/external sources (e.g., stakeholders, customers, suppliers, regulators) to monitor compliance.
- Coordinates via teamwork; may provide technical/behavioral expertise and guidance.
Basic Qualifications:
- Bachelor’s degree in Sciences/Technical/Engineering or related field with 3 years in a cGXP manufacturing environment.
- OR advanced degree in the same fields with experience in a cGXP manufacturing environment.
Preferred Qualifications:
- Experience with deviation management systems (e.g., Trackwise, Phenix).
- Knowledge of Manufacturing and GXP regulations and guidance.
- Excellent critical thinking and technical writing; excellent written and oral English.
- Proficient with change control requests, CAPAs, and deviation quality systems.
- Experience leading cross-functional teams and facilitating meetings; ability to influence.
- Ability to balance speed and quality; tracks deviations/CAPAs/CCRs to meet timelines.
- Experience with project management, troubleshooting, investigation, and root cause analysis in a GXP environment.
- Operations experience in Quality Assurance, Quality Control, Manufacturing Technical Support, Facilities Engineering, and/or Automation.
- Ability to gown and gain entry to manufacturing areas.