Sanofi Group Manager, Compliance US - Vaccine in Swiftwater, Pennsylvania
The Manager Quality Compliance will 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 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
A Bachelor’s Degree is required
5-10 years’ experience in a cGMP production facility
1-3 years' experience working with Quality systems
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.
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.