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Compliance Official Manager, Shop Floor Quality QA-Swiftwater, PA

Swiftwater, Pennsylvania

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Overview

Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Our Sanofi Pasteur Swiftwater, PA site, where we both research and manufacture vaccines since 1897, has had a tremendous impact on global health and the quality of human life. Nestled among the Pocono Mountains in Swiftwater, Pennsylvania, Sanofi Pasteur is home to state-of-the-industry facilities—and a rich and unique history. Our Swiftwater campus is more than 500 acres, housing 44 buildings and encompassing more than one million square feet of building space. Many of our facilities, while bright and modern, still retain the rustic charm of the original stonework.

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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

Summary of purpose/major responsibilities

This Quality position ensures Quality compliance oversight with cGMP, Regulatory, and Internal requirements regarding the manufacturing, testing, and distribution of products through real-time, on-the-floor presence.

This Quality position oversight involves, but is not limited to… auditing, deviation support, auditing of manufacturing areas for performance, audit support, documentation support, trending, risk assessments, adherence to the program as documented, and review of area release documentation and following non-routine events.

Key accountabilities

35% of time On Floor Support

15% Technical Advice

10% Leadership / Strategy

10% Auditing / Audit Support

10% Deviation Support

10% Continuous Improvements

5% Inspection Support

5% Trending / Metrics

Context of the job/major challenges

This Quality position ensures Quality compliance oversight with cGMP, Regulatory, and Internal requirements regarding the manufacturing, testing, and distribution of products through real-time, on-the-floor presence. 

This Quality position ensures Quality compliance oversight for auditing, deviation support, technical advice, real-time coaching, support traffic and gowning, aseptic technique, cleaning and disinfection, aseptic process simulation procedures, gowning scenario decision making, documentation support, trending analysis, risk assessment, adherence to site programs, area releases, and other non-routine events.  This includes attending manufacturing shift changes, L2 board reviews, inspection support, risk assessments, and providing quality input as applicable or escalating as necessary.

This Quality position ensures Quality compliance oversight for specific on the floor tasks, but not limited to:

  • Area Creation & Release
  • Environmental Monitoring Release
  • Out of Service Creation & Release
  • Tank Hook Ups
  • Line Clearances
  • Water Leaks
  • Aseptic Simulations / Interventions

Dimensions/Scope

This position has oversight of technicians/managers specifically at Swiftwater, PA. 

This position is 1st shift, Tues-Sat, and subject to move based on business justification.

Requirements

Education/experience

Bachelor’s Degree or Higher in a science-based field.

A minimum 3-5+ years’ experience, in a Quality Role, in a cGMP controlled/ pharmaceutical industry with a demonstrable working knowledge of documentation review, deviation investigation, contamination control, disinfection, quality assurance, aseptic processing, cGMPs and regulatory requirements. 

Preferred experience in decision making, leadership, auditing, and deviation investigations.

Certifications

N/A

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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