Senior Manager Quality

Philip Morris International•Aurora, CO

27d•Hybrid

About The Position

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. We are hiring a Senior Manager, Quality in Aurora, CO! The Senior Leader Quality is accountable for owning and governing the effective deployment of PMI’s Quality Management System (QMS) at site level, ensuring full compliance of manufactured products (combustible cigarettes, RRP and other regulated product categories) with FDA regulations, PMTA commitments, PMI standards, and product specifications, including tolling where applicable. Acting as the site Quality authority, the role ensures continuous FDA inspection readiness, and disciplined change and validation management. The role drives zero loss performance, strengthens Quality culture, and enables innovation aligned with PMI U.S. Quality strategies.

Requirements

University degree required.
7+ years of Quality Assurance experience in tobacco, pharmaceutical, food, or similar FDA-regulated industries.
At least 2 years in a people leadership role, with accountability for audits, inspections, and regulatory compliance.
Advanced knowledge of FDA regulatory frameworks, QMS, validation, change control, and inspection readiness in highly regulated manufacturing environments.
Strong understanding of post-market surveillance, complaints management, and recall processes.
Proven leadership and influencing capability to embed quality ownership and compliance discipline across functions.
Strong financial and performance management acumen.

Nice To Haves

Master’s degree in Biological Sciences, Physical Sciences, Chemistry, Engineering, or equivalent preferred.

Responsibilities

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, and changes are validated, maintained, and governed using risk-based approaches and formal change management.
Address complex quality, challenges by assessing risk, system interdependencies, and potential FDA impact.
Apply structured, risk-based problem-solving to deliver compliant, sustainable solutions.