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Contract Mfg Compliance Specialist-Waltham-MA

Waltham, Massachusetts

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Overview

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Culture: Play to Win

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    Collaboration

Benefits

  • Health & Wellness

    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

  • Financial

    Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.

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    At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.

  • Work/Life Balance

    Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.

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Quote

"My family is everything to me. They are proud of the work I do, educating the community and ensuring that no Pompe patient is left behind."

C. Richard Cioci Clinical Science Associate – Pompe Ontario East & Atlantic

"I am continually impressed at the dedication that Sanofi has to the patients for whom we provide solutions."

Suncére Hernandez Area Business Manager, Multiple Sclerosis

"Patients are at the center of our work. Our teams focus on advancing transformational therapies, and expanding patient access to our medicines."

Mouhamed Gueye US Head Medical, Rare Blood Disorders

Responsibilities

JOB DESCRIPTION:

The Contract Manufacturing Compliance Specialist provides compliance and quality support for applicable GxP processes within the Quality Management System (QMS).  The candidate has responsibilities supporting the following areas: (1) Supplier Management including quality agreement management and external inspection and response management, and tracking; (2) Internal Audit Program and inspection readiness (3) Product Complaint Investigation management; (4) Risk Management and (5) Metrics compilation and reporting. 

MAIN RESPONSIBILITIES:

  • Maintain compliance requirements for established QMS processes and procedures
  • Train and maintain proficiency in using electronic quality systems for managing change control, deviations, CAPA, etc.
  • Complete analysis, identify issues and provide recommendations for compliance improvements; if applicable, help remediate processes and systems in accordance with company standards and regulatory requirements
  • Participate on projects or assignments and ensure objectives are appropriately set and met
  • Demonstrate understanding of and ability to interpret US and international GxP regulations
  • Interact and coordinate with internal and/or external stakeholders

BASIC QUALIFICATIONS :

  • Bachelor's degree
  • 4+ years of similar experience within the Biotech/Pharmaceutical industry with 6+ industry years' preferred.   

OTHER SKILLS / COMPETENCIES:

  • Works effectively and cooperatively with others - Establishes and maintains good working relationships
  • Attention to detail, strong verbal and written communications, effective time management, and organizational skills
  • Ability to multi-task and work in a fast paced and dynamic environment
  • Driven with a strong focus on goals

ABOUT Sanofi Biologics External Supply:

We manage relationships with critical Contract Development & Manufacturing Organizations as suppliers of drug substance, drug product, finished goods and manufacturing services to Sanofi Biologics, Sanofi Genzyme Business Unit and other business units. And we oversee the external network as if it were a multi-product site, effectively managed and fully integrated into Sanofi’s business systems and quality systems.

Great place to work with stellar reputation, inspirational leadership and positive track record of career evolution at Sanofi. Excellence in external supply network management (timely launches, flexible, reliable & competitive supply)

Contribute to 1/3 of Biologics industrial output for therapies of immunology, multiple sclerosis, rare disease, oncology, and rare blood disorders.   

Attract internal and external talents and enable them to develop within Sanofi.

We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. VEVRAA Federal Contractor

We Request Priority Protected Veteran and Disabled Referrals for all our locations.

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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