Senior Compliance Specialist

Job Title: Senior Compliance Specialist

Location: Framingham, MA

About the Job

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.

The Senior Compliance Specialist 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.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• 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.

About You

QUALIFICATIONS:

• Associate’s degree in Life Sciences or related field with 6+ years’ experience – required.  Bachelor’s degree in Life Sciences or related field with 4+ years’ experience - preferred. 

• Exemplary technical writing skills, experience with deviation investigations and corrective action plans – required. 

• Experience with deviations and CAPA events in a manufacturing operations setting – preferred.

• 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

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

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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Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.

North America Applicants Only

The salary range for this position is:

$74,250.00 - $107,250.00

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.