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Senior Associate Compliance, Waltham, MA

Waltham, Massachusetts

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Overview

This is where ideas are pioneered and innovation takes shape. Where being a health journey partner takes shape — and where you can help bring ideas to life. Research & Development is the heart of our business. The clinical research, clinical development and clinical trials that are essential to new product development all happen here. Preclinical drug safety is rigorously tested and our program management teams ensure everything stays on track. Together, our R&D team ensures that our pipeline is protected and productive — and that the early stages of development run smoothly and effectively. Come be part of this journey.

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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.

  • Culture

    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

"I give thanks to my powerhouse team for reminding me that I have a support system behind me, pushing me forward."

Bob Shustack Head of Global Support Functions Finance, North America

Responsibilities

The Compliance Specialist provides compliance and quality support for applicable GxP processes within the Quality Management System (QMS).  The candidate is involved in the review and disposition of Bioverativ products manufactured at Contract Development & Manufacturing Organizations (CDMOs).

MAIN RESPONSIBILITIES

  • Maintain compliance requirements for established QMS processes and procedures
  • Provide support to product disposition process by reviewing completed batch documentation and verifying GxP and Bioverativ requirements are met
  • 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 required
  • 2+ years of experience in a compliance role within the Biotech/Pharmaceutical industry

COMPETENCIES / OTHER SKILLS

  • 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

Sanofi US Services, 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.

#GD-SG

#LI-GZ

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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