Manager Quality Engineering

Philip Morris International U.S.; Aurora (CO); On-site; USD 115,000 - 140,000; Full time

Job summary

Philip Morris International (PMI) seeks a Quality Engineering Manager at its Aurora, Colorado facility to lead qualification activities and ensure GMP-compliant manufacturing and lab systems throughout their lifecycle.

The role drives validation programs, risk management, change control, and continuous improvement to support quality, compliance, and business growth.

Qualifications

• Bachelor's degree in Engineering or related field; Master's preferred.
• 7+ years in quality, engineering, validation, manufacturing, or other regulated industry.
• Experience leading teams and cross-functional initiatives with GMP knowledge.

Responsibilities

• Lead validation and qualification of manufacturing processes, equipment, utilities, cleaning processes, and laboratory systems.
• Oversee QC/QA governance and Master Batch Records compliance.
• Drive CAPAs, investigations, deviations, and quality events.
• Establish KPIs and lead continuous improvement in quality systems.
• Lead a high-performing Quality Engineering team and cross-functional collaboration.

Skills

Quality Engineering

Leadership

Cross-functional collaboration

GMP knowledge

CSV / 21 CFR Part 11

Education

Bachelor's degree in Engineering

Master's preferred

Job description

Be a Part of a Revolutionary Change! At Philip Morris International (PMI), we're transforming our business and building our future on one clear purpose: delivering a smoke-free future. With that transformation comes exciting opportunities to innovate, grow, and make a meaningful impact.

Quality Engineering Manager

We are seeking an experienced Quality Engineering Manager for our Aurora, Colorado facility to lead Quality Engineering activities and ensure manufacturing processes, laboratory systems, equipment, utilities, cleaning processes, and computerized systems remain qualified and validated throughout their lifecycle. This role drives validation programs, quality risk management, change control, and continuous improvement initiatives that support compliance, product quality, operational excellence, and business growth.

Annual Salary Range: $115,000-$140,000

Key Responsibilities

Quality, Compliance & Safety

• Ensure compliance with GMP, EHS, sustainability, company standards, and regulatory requirements.
• Maintain audit and inspection readiness; support internal, customer, and regulatory audits.
• Promote a culture of quality, compliance, accountability, and risk management.

Validation & Qualification

• Develop validation strategies, governance processes, and the Site Validation Master Plan.
• Lead qualification and validation of manufacturing processes, equipment, utilities, cleaning processes, laboratory systems, and computerized systems.
• Review and approve validation protocols, reports, risk assessments, and related documentation.
• Serve as site validation SME, providing training and technical guidance.

Quality Systems & Continuous Improvement

• Oversee product specifications and Master Batch Record (MBR) governance, ensuring compliance and effective change implementation.
• Lead investigations involving complaints, deviations, nonconformances, and quality events; drive effective CAPAs.
• Establish and monitor KPIs supporting validation, compliance, quality systems, and change management.
• Drive continuous improvement initiatives that enhance compliance, product quality, and operational performance.

Leadership & Collaboration

• Lead and develop a high-performing Quality Engineering team.
• Promote collaboration, accountability, and continuous improvement.
• Partner cross-functionally to support strategic initiatives, business projects, and new product introductions.

Qualifications

• Bachelor's degree in Engineering, Chemistry, Biological Sciences, Manufacturing, Quality, or related technical field required; Master's preferred.
• 7+ years of experience in Quality, Engineering, Validation, Manufacturing, or another regulated industry.
• Demonstrated leadership experience managing teams and cross-functional initiatives.
• Strong knowledge of GMP, quality systems, validation methodologies, and Quality Risk Management.
• Experience with CSV, data integrity, electronic quality systems, and knowledge of 21 CFR Part 11 preferred.

Philip Morris International (PMI) is an Equal Opportunity Employer. PMI provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable federal, state, or local law. PMI is committed to providing reasonable accommodations to qualified individuals with disabilities.

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