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Manager Compliance US

Swiftwater, Pennsylvania

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Overview

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Mouhamed Gueye US Head Medical, Rare Blood Disorders

Responsibilities

POSITION OVERVIEW

**1st shift - Monday- Friday**

Location: Swiftwater, PA

Job Description:

The Manager Quality Compliance will ensure compliance with cGMP, regulatory, and internal requirements regarding the manufacturing, testing, and distribution of products through formal QA Audits, investigations, training, and recommendations to procedures. 

Position Responsibilities:

  • Evaluate and provide QA recommendations on all products, systems, and issues that are/may be affected by regulatory or cGMP requirements.

  • Participate in project teams involved with the facilities, processes, and equipment for the manufacturing of vaccines

  • Ensure a constant state of inspection readiness and  all audit observations are addressed

  • Support FDA and international regulatory bodies during site inspections

  • Provide input and guidance to the team conducting incident investigations

  • Make recommendations to department management regarding results of investigations and process improvements

  • Manage our quality systems to ensure that corrective and preventative actions are completed

  • Provide support to functional areas regarding the Change Control System

Basic Qualifications:

  • Bachelor’s Degree is required with 5-10 years’ experience in a cGMP production facility with at least 1-3 years' experience working with Quality systems

Technical Competencies:

  • Quality Assurance experience in a Pharma/Vaccine production facility

  • Working knowledge of cGMPs and regulatory requirements

  • Knowledge of vaccines/biologics products and associated technologies

  • Previous experience with upstream processing of Drug Substance and/or Quality Control testing  in a cGMP facility

  • The ability to work on cross-functional project teams

  • Meet/Exceed project timelines/deliverables

  • Experience with Quality Systems including SAP, Quality eDoc, LabWare, TrackWise, and MS Office

  • Strength in several LEAD Competencies - Think Strategically, Lead Teams, Act for Change, Strive for Results, Cooperate Transversally, Commit to Customers, Make Decisions

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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