Quality Systems Leader — Unified QMS & Compliance

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

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.