Sr Manager Quality Systems

Philip Morris International; Wilson (NC); On-site; USD 136,000 - 170,000; Full time

Job summary

Philip Morris International (PMI) seeks a Manager Quality System to lead a unified QMS in an FDA-regulated environment. You will harmonize two existing systems into one framework, ensuring compliance and driving continuous improvement.

Responsibilities include developing the Quality Manual, managing documentation, and leading a quality team. You will support inspections and audits while cultivating a strong quality culture across cross-functional teams.

Qualifications

• Requires Master’s degree in Engineering/Life Sciences or bachelor’s with equivalent experience.
• 10+ years of Quality Management in a regulated industry.
• Experience with quality records, CAPAs, non-conformances, and electronic QMS.
• Knowledge of ISO 9001 standards, regulatory requirements, manufacturing processes, and documentation management.
• Experience developing and deploying quality training programs.
• Strong digital, analytical, leadership, communication, and organizational skills.
• Ability to manage ambiguity, lead change, and drive continuous improvement.

Responsibilities

• Lead development and implementation of a unified QMS aligned with FDA regulations.
• Develop, maintain, and update the Quality Manual for regulatory compliance.
• Oversee quality documentation, records management, and lifecycle governance.
• Lead QMS training strategies and programs to ensure competency and compliance.
• Govern NC, DP, and CAPA processes and related activities.
• Drive continuous improvement and foster a quality culture across the organization.
• Support regulatory inspections, audits, and inquiries with prepared documentation.
• Lead, develop, and mentor a high-performing quality team.

Skills

Quality Management

Regulatory compliance

Leadership

Training programs

Documentation management

Problem solving

Education

Master’s degree in Engineering/Life Sciences

Bachelor’s degree with equivalent experience

Tools

QMS software

Electronic Quality Management System

Document control systems

Job description

At Philip Morris International (PMI), we’re transforming our business and building our future on one clear purpose: delivering a smoke-free future.

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.

Principal Accountabilities

• 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.

Skills and Competencies

• 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.

This role requires a proactive leader who can successfully integrate quality processes, ensure regulatory compliance, and foster a culture of quality excellence across cross-functional teams.

Annual Base Salary: $136,000 - $170,000

Philip Morris International Inc.'s U.S. businesses are invested in America's future and advancing a smoke-free nation. The businesses are committed to providing the approximately 25 million legal-age consumers who smoke cigarettes with better, smoke-free alternatives and to ensuring the products are marketed responsibly. From PMI's global headquarters in Stamford, CT, and other locations nationwide, PMI U.S. contributes leadership, jobs, investment, and innovation in the U.S. The U.S. businesses employ more than 3,000 people across America and operate product manufacturing facilities. For more information, please visit www.uspmi.com. Philip Morris International (PMI) is an Equal Opportunity Employer.

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