Senior Manager Quality

Senior Manager, Quality – Aurora, CO

Be a part of a revolutionary change! At Philip Morris International (PMI), we’ve chosen to do something incredible. We’re totally transforming our business and building our future on one clear purpose – to deliver a smoke‑free future.

With huge change comes huge opportunity. So, if you join us, you’ll enjoy the freedom to dream up and deliver better, brighter solutions and the space to move your career forward in endlessly different directions. Our success depends on people who are committed to our purpose and have an appetite for progress.

• Ensure compliance with PMI and U.S. legal requirements related to Environment, Health, Safety, Sustainability, and Product Safety, preventing personnel, asset, consumer, or societal loss.
• Promote an interdependent safety and compliance culture, embedding preventive and predictive risk management approaches in line with OPEN+ / IOS principles.
• Ensure quality governance supports FDA expectations for product consistency, consumer protection, and regulatory transparency.

• Own deployment and effectiveness of the site Quality strategy, aligned with PMI U.S. Quality priorities, FDA regulatory requirements, and PMTA commitments.
• Ensure a permanent state of FDA inspection readiness, including governance of documentation, evidence packages, data integrity, and system traceability.
• Sponsor and govern quality initiatives, ensuring alignment, disciplined execution, and sustained compliance outcomes.
• Drive simplification, automation, and digitalization of quality processes to strengthen inspection readiness.

• Ensure robust non‑conformance management processes are effective, including deviations, CAPAs, consumer complaints, and market feedback.
• Govern timely, compliant investigations and ensure root‑cause analysis.

• Lead site readiness for FDA inspections, internal audits, and third‑party regulatory assessments, ensuring consistent availability of complete, accurate, and defensible evidence.
• Deploy a risk‑based audit and self‑inspection program, reviewed annually and aligned with FDA inspection focus areas.
• Act as a senior Quality interface during regulatory inspections, ensuring controlled, accurate, and timely responses.

• Ensure quality control activities are executed for incoming materials, ingredients, semi‑finished and finished products, in compliance with FDA regulations, PMI requirements, and product specifications.
• Define and monitor quality KPIs and compliance metrics to proactively identify trends, risks, and improvement opportunities.
• Lead Quality Management Reviews, ensuring transparent communication of compliance status, risks, and improvement actions with Operations, Regulatory, and senior leadership.

• Define and lead the Quality site budget, ensuring alignment with strategy, zero loss journey, and committed budget.
• Drive productivity by identifying and eliminating quality‑related losses, while ensuring no compromise to quality or compliance.
• Ensure disciplined performance tracking, reporting, and escalation of risks.

• Build and lead a high‑performing Quality organization, ensuring capability, engagement, and accountability.
• Develop current and future Quality capability through qualification matrices, role‑based training paths, and succession planning, with specific focus on FDA‑critical competencies.
• Embed a strong data integrity, compliance, and inspection‑ready mindset across the organization.

• Act as the Authorized Person (or designated delegate) for batch release, ensuring products are manufactured, tested, and documented in compliance with QMS, FDA expectations, and product specifications.
• Ensure completeness, accuracy, and integrity of batch records and release documentation, with full traceability.
• Own the Site Validation Master Plan, ensuring manufacturing processes, systems,…