QA Manager — Regulated Manufacturing & QMS

Philip Morris International U.S.; Aurora (CO); On-site; USD 132,000 - 165,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with employer contributions and

Matching

Job summary

Philip Morris International (PMI) U.S. is seeking a Quality Assurance Manager to lead the site’s Quality Management System (QMS) and the QA team.

You will ensure compliance with PMI, FDA, ISO, and regulatory requirements, drive audit readiness, CAPA oversight, and continuous improvement while developing team capabilities and a strong quality culture. You will oversee internal audits, deviations, investigations, and risk management, and provide QA leadership for site projects and strategic

Qualifications

• Bachelor's or Master's in Biological Sciences, Physical Sciences, Engineering, Pharmacy, Chemistry, or related field.
• 5+ years of QA/QMS experience in a regulated manufacturing environment.
• Proven leadership experience managing teams in a regulated setting.
• Experience with audits, inspections, CAPA systems, management reviews, and compliance programs.
• Strong knowledge of QMS, FDA and ISO requirements, risk management, CAPA, document control, and training systems.
• Fluent in English.

Responsibilities

• Lead, coach, and develop QA personnel.
• Manage performance, employee development, training, and succession planning.
• Lead and maintain the site QMS.
• Ensure compliance with PMI standards, FDA regulations, ISO requirements, and site procedures.
• Maintain audit and inspection readiness and support regulatory inspections.
• Lead internal audits and oversee audit responses and corrective actions.
• Oversee deviations, investigations, non-conformances, and CAPA programs.
• Drive root cause analysis, risk management, and continuous improvement initiatives.
• Provide QA leadership for site projects, strategic initiatives, and change management activities.

Skills

Leadership

Quality assurance

Audits & CAPA

Regulated environment

English fluency

Education

Bachelor's or Master's in a regulated field

Job description

Philip Morris International (PMI) U.S. is seeking a Quality Assurance Manager to lead the site’s Quality Management System (QMS) and the QA team.

You will ensure compliance with PMI, FDA, ISO, and regulatory requirements, drive audit readiness, CAPA oversight, and continuous improvement while developing team capabilities and a strong quality culture. You will oversee internal audits, deviations, investigations, and risk management, and provide QA leadership for site projects and strategic