Sanofi Group Manager Compliance US-Swiftwater, PA in Swiftwater, Pennsylvania
Ensure compliance with cGMP, regulatory and internal requirements regarding the manufacturing, testing and distributing of products through formal QA Audits, investigations, training and recommendations to procedures. 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 that all audit observations are addressed
Interface with FDA and international regulatory bodies during site inspections
Review and Close incident investigations including final product disposition decision
Provide input and guidance to the team conducting the investigation
Make recommendations to department management regarding results of investigation and process improvements
Manage our quality systems to ensure that corrective and preventative actions are made
Provide support to functional areas regarding the Change Control System
5-7 years’ experience in a cGMP production facility
Minimum of 2 years in a Quality Assurance role that includes final closure review of deviation/non-conformance investigations and batch disposition determination.
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.
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.