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Deputy Director Quality Assurance, Shop Floor Quality

Swiftwater, Pennsylvania

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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Responsibilities

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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