Sanofi Group Quality Compliance Manager - Vaccine in Swiftwater, Pennsylvania
Position S u mmary:
Ensure compliance with cGMP, regulatory, and internal requirements regarding the manufacturing, testing and distributing of products through formal QA audits, change controls, investigations, development of corrective and preventative actions, training and review and approval of procedures, protocols and reports. Evaluate and provide QA recommendations on all products, systems, and issues that are affected or may be affected by regulatory or cGMP requirements.
This position is a 1st shift, Mon-Fri, and subject to move based on business justification.
Ensure a constant state of inspection readiness and that all audit observations are addressed quickly and completely to maintain readiness levels.
Complete incident investigations through the review and approval process in response to any unexplained events encountered during manufacturing or out-of-specification lab results for functional areas. Provide input and guidance to the team conducting the investigation. Make recommendations to department management regarding results of investigation and process improvements, when necessary. Manage the CAPA system to ensure that corrective and preventative actions are developed and implemented.
Perform cGMP audits within functional areas by conducting a thorough review of processes and documentation. Identify and communicate cGMP compliance deficiencies to Upper Management, recommend appropriate corrective actions when necessary, and perform necessary follow up with respective functional area management to ensure cGMP audit observations are implemented.
Provide support to functional areas regarding the Change Control System by providing assessments, work closure and follow up. Recommend documentation and supporting data to include in the Change Control Request to ensure that enough information is provided to the Change Control Board so that an informed decision can be made.
Provide final signatory review and approval for SOPs, SWIs, and Master Manufacturing Records to ensure compliance with cGMP, regulatory and internal requirements.
Interact successfully within the highly energized production and regulatory environments.
Interact regularly with site counterparts relating to manufacturing, testing, disposition, and cold chain documentation. The incumbent must be able to communicate clearly the cGMP requirements.
Provide shop floor quality support to ensure manufacturing activities are performed in compliance with effective SOPs & SWIs.
Provide guidance/decision to resolve compliance issues and procedural errors in real time.
Bachelor's Degree in Science, with 3-5 years experience in a GMP regulated environment.
1-2 years in a Quality Assurance role preferred which 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.