Mgr Supplier Quality External Auditor-Swiftwater, PA
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Our Sanofi Pasteur Swiftwater, PA site, where we both research and manufacture vaccines since 1897, has had a tremendous impact on global health and the quality of human life. Nestled among the Pocono Mountains in Swiftwater, Pennsylvania, Sanofi Pasteur is home to state-of-the-industry facilities—and a rich and unique history. Our Swiftwater campus is more than 500 acres, housing 44 buildings and encompassing more than one million square feet of building space. Many of our facilities, while bright and modern, still retain the rustic charm of the original stonework.
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Comprehensive coverage including medical, dental, vision, and health and wellness programs.
Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.
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The position, Manager – External Audit, Supplier Quality, is predominantly an external auditor position. The annual supplier audit schedule must be completed to ensure compliance to local, global, and regulatory requirements. This individual is responsible for auditing suppliers, contract manufacturing organizations, test labs, and service providers in accordance with local and global Sanofi procedures. They are also responsible for facilitating supplier-related investigations and completing raw material/commodity actions required to support manufacturing operations.
The Manager – External Audit, Supplier Quality is responsible for the planning and execution of supplier audits. Activities at supplier locations and support of our Operations often occur during active production events, and the individual must be flexible to allow for the full understanding of the process or issue faced.
The individual is required to work closely with various departments across the site. The position requires strong interpersonal skills to manage multiple and sometimes conflicting priorities. Some interaction with global counterparts is expected. The incumbent will be involved in small to large scale projects where he/she is expected to lead the entire team or serve as a technical member. The individual is expected to make decisions based on established policies and procedures.
This position requires travel. The job holder can expect to spend up to 40% of their time away from the site, with the possibility of short periods of time ranging up to 80% travel.
This position is responsible for the supplier management process. This includes auditing a base of ~400 quality managed suppliers with audit frequencies driven by a risk based approach. The individual is also responsible for facilitating a portion of the more than 100 supplier issue investigations completed each year.
The position requires the ability to work in a diverse environment and draw upon experience in determining the difference between critical and non-critical issues and their impact on the business. The position requires a background in GMP operations in an FDA regulated environment. This individual is also responsible for performing qualification and “for cause” audits to bring new materials and suppliers into the approved state. The individual may be required to work as a lead auditor and as a member of an audit team. As this individual is the interface between Sanofi and our supply base, it is expected that a high level of professionalism, respect for the suppliers, and a non-biased approach are employed.
The ideal candidate will possess a strong background in Primary Packaging components related to injectable products. Additionally, ASQ or other quality-related certification is prefered but not required.
Minimum Bachelor degree, with at least 5 years relevant pharmaceutical industry experience; extensive experience in the industry may offset the need for a Bachelor degree.
The individual must demonstrate an in-depth knowledge of regulatory requirements, auditing practices, and investigation skills. Strong writing and communication, organization, and interpersonal skills 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.
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.
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