Compliance Manager

Ensure compliance to cGMP, regulatory, and internal requirements regarding the manufacture, testing and distribution of sanofi pasteur products through formal QA audits, investigations, training and recommendations to procedures. Required to evaluate and provide QA recommendations on all products, systems, and issues that are affected or may potentially be affected by regulatory or cGMP requirements.Perform GMP/GLP audits within functional areas as well as outside vendors by a thorough review of processes and documentation. This is done in order to identify and communicate GMP/GLP compliance deficiencies to management, recommend corrective actions when necessary, and perform necessary follow up to ensure cGMP compliance. This includes the maintenance and use of the Quality Assurance Audit Log.Provide daily floor coverage to support compliant production, development, and testing of all products within sanofi pasteur USA for functional areas. This floor coverage shall include, but not be limited to, training, communication, and auditing to achieve the enhancement of our quality operations.Support the Change Control System by providing training, input, and follow up for functional areas as needed.Provide final review of SOPs, SWIs, and Master Manufacturing Records.Completes incident investigations in response to any unexplained events encountered during manufacturing or out of specification lab results for functional area. This involves a thorough investigation of the incident and recommendations to department management where applicable. Must manage the CAPA system to assure that corrective and preventative actions are made and follow up on. Attend Material Review Board meetings for incident investigations that are being reviewed by the board for functional areas. Maintain Incident Investigation Reporting System to assure incident investigations are logged and tracked to completion.Provide QA representation on all Product and Process Teams associated with functional areas within IO. Provide leadership and direction to assure products and processes are of the highest level of compliance and quality.Performs special projects are assigned by Head of Compliance.Weekend Shift... Saturday-WednesdayWe are an equal opportunity employer M/F/D/V
REQUIREMENTS
BS/BA in Life Sciences required, MS preferred.
Minimum 5 years manufacturing experience, Minimum 2 years Quality Assurance experience.