Director, Multi-Site Quality Transformation

RXinsider LTD.; Exton (PA); On-site; USD 150,000 - 190,000; Full time

Job summary

West Pharmaceutical Services seeks a Director of Quality Assurance to drive Operating Unit quality governance and harmonization across three manufacturing sites. You will lead multi-site improvement initiatives, standardize quality processes, and deliver executive-level visibility into performance metrics.

The role requires 10+ years in FDA-regulated environments, strong cross-site leadership, and expertise in change control, document management, and risk-based quality practices.

Qualifications

• Bachelor's degree in science, engineering, or related field is required.
• 10+ years of progressive quality experience in FDA-regulated medical device or combination product environments.
• Experience leading cross-site or multi-site quality initiatives and interfacing with external customers.

Responsibilities

• Accountable for Operating Unit–level governance of change control and document management across three sites.
• Lead cross-site process improvement initiatives to reduce cycle times and improve transparency.
• Own OS quality KPI governance and develop executive dashboards and performance insights.
• Serve as primary quality interface for key pharmaceutical customers and lead quality discussions during business reviews.
• Operate in a matrix environment, influencing without direct authority and ensuring alignment with quality standards.

Skills

Executive presence

Cross-site leadership

Lean/Six Sigma

Regulatory knowledge

Matrix leadership

Education

Bachelor's Degree in Science, Engineering, or related field

Tools

Excel

PowerPoint

Job description

West Pharmaceutical Services seeks a Director of Quality Assurance to drive Operating Unit quality governance and harmonization across three manufacturing sites. You will lead multi-site improvement initiatives, standardize quality processes, and deliver executive-level visibility into performance metrics.

The role requires 10+ years in FDA-regulated environments, strong cross-site leadership, and expertise in change control, document management, and risk-based quality practices.