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Manager Internal Audits

This position is responsible for the preparation and execution of site wide data integrity audits focusing on written records and electronic documentation, as well as the management of resultant corrective actions.  The incumbent must interact successfully within the highly energized production and regulatory environments Demonstrated prior experience in Data Integrity understanding and audit techniques is desired Responsible for the auditing of compliance to regulatory requirements, global requirements and internal requirements across Vaccine Industrial Affairs to ensure GMPs are followed  in a compliant manner.  The scope of this auditing function includes VIA manufacturing, testing of license product and RA supporting VIA.  Accountable for ensuring a constant state of inspection readiness as it applies to GMP compliance. Working cross functionally with VIA management to ensure corrective actions to findings are managed to timely completion.  Responsible for support of regulatory inspections as a member of the back room team and/or shop floor pre-inspections.  Demonstrated prior experience in Data Integrity understanding and audit techniques is desired.  This position requires strong interpersonal skills to manage multiple and often conflicting perspectives.  Auditing activities often occur during active production events, and the auditor must be both flexible and firm to ensure that auditing activities are conducted in a timely manner with minimum disruption to the audited area.  Personnel in this role must have strong leadership and negotiation skills to drive the remediation of identified deficiencies, oftentimes through dynamic organizational shifts. This position is responsible for the preparation and execution of site wide data integrity audits focusing on written records and electronic documentation, as well as the management of resultant corrective actions.  The incumbent must interact successfully within the highly energized production and regulatory environments. The incumbent must be able to communicate clearly the cGMP requirements.  Methods of high level communication include both written and verbal format.  The incumbent must determine severity of deficiencies observed, communicate deficiencies and collaborate and obtain buy-in from the auditee for robust CAPA. Bachelor's Degree in life sciences.  A minimum 5 years experience in a cGMP controlled/pharmaceutical industry, including at least 5 years experience a regulated Quality environment is required.  Prior auditexperiencedesired, ASQ-CQA certification desired. Thorough knowledge of cGMPs and regulatory requirements are required. Experience interacting with regulatory agencies and health authority inspections is required.  Excellent organizational, interpersonal and leadership/teamwork abilities are required. 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. job id R2477989
Salary Range: NA
Minimum Qualification
5 - 7 years

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