Quality Project Manager - Sterilization

Description

This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week. No relocation is provided for this opportunity.

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun.

A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

The Quality Project Manager – Sterilization is responsible for leading and executing sterilization‑related quality initiatives across manufacturing sites. This role combines strong sterilization technical expertise (EtO, steam, gamma) with structured project management capabilities to drive standardization, compliance, continuous improvement, and quality maturity. The position supports the development and implementation of standardized sterilization processes, validation programs, and QMS improvements while ensuring compliance with FDA, ISO 13485, and applicable regulatory standards.

This role works cross‑functionally with Engineering, Operations, Regulatory, R&D, and Quality teams to execute projects on time, within scope, and within budget.

• Support the development, harmonization, and deployment of standardized sterilization procedures and quality practices across multiple sites.
• Coordinate sterilization validation activities, including initial process validations, revalidations, and annual re‑qualifications to maintain a validated state.
• Author, review, and approve sterilization protocols, validation reports, technical documentation, and related procedures in accordance with internal standards and regulatory requirements.
• Ensure compliance with FDA regulations (21 CFR 820), ISO 13485, applicable cGMP requirements, and other global regulatory standards.
• Support environmental monitoring programs and implement risk‑based validation and control strategies.
• Monitor, track, and trend sterilization process data to identify improvement opportunities, ensure process capability, and maintain compliance.
• Participate in regulatory inspections and audits and provide front‑room and back‑room support for sterilization‑related activities.
• Lead cross‑functional sterilization and quality improvement projects from initiation through closure, ensuring alignment with business objectives.
• Develop project charters, timelines, resource plans, and budgets, and identify, assess, and mitigate project risks throughout the project lifecycle.
• Manage project scope, schedule, and cost controls using structured project management methodologies.
• Assemble and coordinate cross‑functional project teams, define clear deliverables, and ensure accountability.
• Measure and report project performance using defined KPIs and quality metrics and communicate progress, risks, and outcomes to key stakeholders.
• Support standardization and continuous improvement of quality systems and sterilization practices across sites.
• Lead or contribute to CAPA, root cause analysis, FMEA, and broader risk management activities to address quality and compliance gaps.
• Develop, analyze, and report quality performance metrics related to sterilization effectiveness and cost of quality.
• Drive Lean and Six Sigma initiatives to improve sterilization cycle efficiency, strengthen compliance robustness, and optimize cost performance.
• Coordinate corrective and preventive actions…