Quality Project Manager - Sterilization

Quality Project Manager - Sterilization

Requisition

Date:
Apr 7, 2026

Location:

Exton, PA, US, 19341

Department:
Quality

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

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 optimise cost performance.
• Coordinate corrective and preventive actions resulting from customer complaints, audit findings or operational nonconformances.
• Collaborate closely with Engineering, R&D, Operations and Regulatory teams to support product and process transfers, validations and continuous improvements.
• Support evaluation and implementation of new sterilization technologies, industry best practices and process enhancements.
• Ensure proper change control processes are followed, including completion of risk assessments, impact analyses and FMEA documentation.

• Works independently with minimal guidance.
• Develops technical knowledge, requires working knowledge and experience in project management.
• Manages single work streams locally and/or globally and may work across multiple work streams.
• Maintain clear communication paths with stakeholders.
• Conforms with and abides by all regulations, policies, work procedures, instructions and all safety rules.
• Exhibits regular, reliable,…