Senior Associate, Quality Systems

Requisition

Date:
Oct 2, 2026

Location:

Exton, PA, US, 19341

Department:
Quality

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.

In this role, you will be responsible for supporting the governance, harmonization, and continuous improvement of Quality Management System (QMS) processes across the Vantage manufacturing network. Operating at an above-site level, this role provides oversight of key Vantage OU quality processes including Change Management, CAPA, Global Alerts, Management Review, Quality Metrics, and OU-level Document Control. The role partners with site Quality teams and cross-functional stakeholders to ensure consistent implementation, regulatory compliance, risk-based decision-making, and alignment with West enterprise requirements, customer expectations, and applicable standards including FDA, ISO 13485, EU GMP, and other relevant regulatory requirements.

The Senior Quality Specialist – Vantage Operating Unit (OU) reports to the Director, Compliance & Combination Devices.

• Manage and coordinate designated Vantage OU QMS processes, including Change Management, CAPA, Global Alerts, Management Review, Quality Metrics, Tier 4 Reporting, and OU-level Document Control.
• Ensure Vantage OU quality processes are standardized, harmonized, effectively deployed, and consistently applied across all Vantage sites.
• Support governance of the Vantage CAPA process, including CAPA Review Board coordination, escalation, prioritization, timeliness, quality, and effectiveness monitoring.
• Drive systemic root cause analysis, cross-site learning, and risk-based corrective and preventive actions across the Vantage network.
• Provide OU-level Change Control oversight to ensure appropriate impact assessment, cross-site alignment, regulatory/customer considerations, and customer notification where required.
• Identify, monitor, and escalate systemic quality risks, adverse trends, and compliance concerns to appropriate stakeholders and senior leadership.
• Support harmonization of site quality systems into standardized Vantage-level processes and promote best-practice sharing across the network.
• Coordinate and manage Vantage OU Management Review, including consolidation, analysis, and presentation of site quality data and executive-level reporting.
• Coordinate weekly Tier 4 quality metric reporting and ensure data integrity, consistency, and accuracy across the Vantage network.
• Support internal and external audit programs, including process/system audits, audit trend monitoring, inspection readiness, and responses to significant…