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Sanofi Group Senior Compliance Specialist in Framingham, Massachusetts

The Senior Compliance Specialis t uses knowledge of Compliance and GxP to manage investigation and improvement initiatives within Engineering. This position is responsible for performing a variety of tasks under minimal guidance and in accordance with current GMP’s.

Responsibilities include:

  • Assisting Engineering Manager with:

  • Deviation Intake and Closure

  • GEMBA meetings with cross-functional team

  • Major/Critical Deviations - Technical Writing

  • Lot Tagging Adherence

  • Change Control Steps Completion

  • Implement Effectiveness Reviews

  • Practices safe work habits and adheres to Sanofi’s safety procedures and guidelines

  • Participates in cross-functional teams to drive investigation close-outs, determine root cause and implement appropriate corrective and preventative actions

  • Participates on cross functional Continuous Improvement teams with Manufacturing, Validation, Quality, Facilities, Metrology and Maintenance

  • Coordinates SME assessments for all CCR’s assigned to the Facilities and Engineering team

  • Works under general supervision and direction

  • Continuous improvement mindset

  • Performs routine documentation assessments to ensure alignment between SOP’s/Standards

  • Participates in cross functional projects and performs SME assessments for all CCRs assigned to Engineering

  • Effectively demonstrates understanding of GMPs and how it applies to specific responsibilities

Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.

BASIC QUALIFICATIONS:

  • Bachelor’s degree in a non-scientific field with 6 years of related experience in a Quality and/or cGMP environment

  • Associate Degree with 8 years of related experience in a Quality and/or cGMP environment

  • High School Diploma with 12 years of related experience in a Quality and/or cGMP environment

  • Advanced computer proficiency

  • Strong verbal and written communication skills

  • Experience with quality systems

  • Experience with cGMP data review

  • Adherence to on-time closures for quality metrics

  • Advanced technical writing proficiency

Special Working Conditions:

  • Ability to gown and gain entry to manufacturing areas

Preferred Qualifications:

  • Experience in cGXP manufacturing environment

  • Experience in troubleshooting, investigating, and root cause analysis in a GXP environment

Competencies/Skills :

Demonstrated skills in the following areas:

  • Problem solving and critical thinking

  • Advanced technical report writing

  • Verbal and written communication

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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