Manager Quality Assurance

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

Quality Assurance Manager

At Philip Morris International (PMI), we've chosen to do something incredible. We're transforming our business and building our future on one clear purpose: delivering a smoke-free future.

The Quality Assurance Manager leads the site's Quality Management System (QMS) and Quality Assurance team, ensuring compliance with PMI, FDA, ISO, and regulatory requirements. This role drives audit and inspection readiness, CAPA oversight, management review, and continuous improvement while developing team capabilities and promoting a strong quality culture.

Key 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.

What We Are Looking For

• Bachelor's or Master's degree in Biological Sciences, Physical Sciences, Engineering, Pharmacy, Chemistry, or a related field, or equivalent regulated-industry experience.
• 5+ years of Quality Assurance, Quality Systems, or related experience in a regulated manufacturing environment.
• Proven leadership experience managing teams in a regulated environment.
• 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.
• Project and change management experience.
• Fluent in English.

Annual Base Salary Range: $132,000 - $165,000

Benefits

• Medical, dental, and vision insurance
• FSA and HSA options
• 401(k) with employer contributions and 6% match
• Paid vacation, sick time, and holidays
• Paid parental leave
• Company-paid life, AD&D, and disability insurance

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.

#PMIUS

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