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Sanofi Group Deputy Director Quality Assurance, Shop Floor Quality in Swiftwater, Pennsylvania

Deputy Director Quality Assurance, Shop Floor Quality

( Swiftwater PA ) This position is for the Deputy Director of Shop Floor Quality supporting the Antigen manufacturing franchise. The Quality Assurance Deputy Director will provide the leadership, direction, and the overall Quality oversight of the Antigen manufacturing area. Responsible for ensuring the supported areas meet current FDA and International Regulatory Body requirements. Responsible for ensuring that company quality policies, procedures, and standards are consistently met and for setting the strategic quality vision for the areas assigned.

As this is a newly created position, the selected individual will be responsible for developing the shop floor quality program within QA – Antigen, from the ground up. This is a tremendous opportunity that requires an extremely dedicated and driven individual who will work with their peers to quickly and effectively establish this program. The individual will have a team of 10 employees.

Key Responsibilities:

  • Provide Leadership and direction to the manufacturing and support area departments to ensure a constant state of inspection readiness.

  • Accountable for ensuring policies, procedures, and standards are consistently followed and adhered to on a consistent basis.

  • Make recommendations for changes to policies, procedures and standards as appropriate to ensure the highest quality standards are maintained.

  • Provide leadership and direction for the team to ensure Deviations, Change Controls, CAPAs, and regulatory commitments are met on time and within the closure rate standards set for completing commitments making sure that the level of quality is maintained. May include independent investigation to resolve quality issues including recommendations to senior management for corrective and preventative actions to address issues effectively.

  • Responsible for representing the Company and directly interfacing with auditors during regulatory body inspections.

  • Builds and maintains a high performing team of compliance managers, providing effective alignment and communication with functional groups at the site and at other manufacturing sites, to successfully deliver on all commitments.

  • Help in resolution of problems or introduction of changes in their respective areas of responsibility.

  • Provide direction, set performance standards, evaluate, develop performance and inspire direct reports.

  • Provide career development and training advice and set short term and long term goals.

  • Provide regular feedback to direct reports on company and departmental operations.

Basic Qualifications:

  • Bachelor's Degree in Life Sciences

  • 5+ years’ experience in a cGMP controlled/pharmaceutical industry with regulatory requirements

  • 5+ years’ experience in a regulated Quality environment

  • 1year experience in leadership.

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.

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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.

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

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