Sr Manager Quality Systems

Philip Morris International U.S.Wilson, NC
$136,000 - $170,000Onsite

About The Position

The Manager Quality System will lead the development and implementation of a Quality Management System (QMS) for a newly established business area within an FDA-regulated environment. This role will harmonize two existing quality systems into a single framework, ensuring compliance with regulatory requirements and driving continuous improvement.

Requirements

  • Master’s degree in Engineering, Technology, Life Sciences, or a related field, or a bachelor’s degree with equivalent experience.
  • 10+ years of Quality Management experience in a regulated industry, preferably consumer goods, pharmaceuticals, or similar sectors.
  • Experience managing quality records, CAPAs, non-conformances, and electronic Quality Management Systems.
  • Knowledge of QMS principles, ISO 9001 standards, regulatory requirements, manufacturing processes, and quality documentation management.
  • Experience developing and deploying quality training programs.
  • Strong digital, analytical, problem-solving, leadership, communication, and organizational skills.
  • Proven ability to manage ambiguity, lead change, and drive continuous improvement.

Responsibilities

  • Lead the creation, implementation, and maintenance of a unified QMS aligned with Global Directives and FDA regulations.
  • Develop, maintain, and update the Quality Manual to ensure regulatory compliance and alignment with business processes.
  • Oversee quality documentation, records management, and document lifecycle governance.
  • Lead QMS training strategies and programs to ensure employee competency and compliance.
  • Govern key quality processes, including Non-Conformance (NC), Deviation Permits (DP), and Corrective and Preventive Actions (CAPA).
  • Drive continuous improvement initiatives and promote a strong quality culture across the organization.
  • Support regulatory inspections, audits, and inquiries, ensuring readiness and accurate documentation.
  • Lead, develop, and mentor a high-performing quality team, setting objectives and providing ongoing feedback.
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