Director, Quality Programs

Location

Exton, PA – Hybrid, 3 days in office, 2 remote

Kinston, NC/Jersey, PA – 4 days in office, 1 day remote

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 U.S. Government during World War II. 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?

In this role, the individual will serve as a key strategic partner to successfully develop new product platforms for advanced manufacturing products as well as conduct process improvement and harmonization activities for legacy High Value Product (HVP) products in global elastomer & metal sites across value streams. The Director, Quality Programs will provide strategic direction and management oversight to the Quality functions within elastomer & metal sites that are involved in advanced manufacturing production.

This individual applies their experience, expertise, and knowledge of the pharmaceutical industry to lead, organize, direct and execute strategically identified initiatives relating to Quality programs. The role sets and aligns functional strategies and objectives to the overall business strategy on a continuous basis in order to achieve objectives in support of the West Global Elastomers & Primary Containment vision, strategic direction and metrics.

The role partners with the Global Engineering team as well as Product Management, Regulatory, R&D and other Quality functions to ensure quality controls and product requirements are compliant with regulatory, and business requirements / customer expectations throughout the product life cycle.

• The primary responsibility for this role is to collaborate with Elastomers & Primary Containment Leadership in driving global harmonization and enhancement of advanced manufacturing processes and product quality. This entails identifying best practice solutions, harmonizing the processes, implementing the processes and ensuring sustainment of these processes.
• Lead the identification of risks and opportunities for improvements regarding elastomers & metal production processes and quality controls across all advanced manufacturing sites and work with all levels within the organization including SMEs in leading, establishing and executing a strategy for improvement.
• Evaluate existing Quality processes to identify discrepancies and areas for harmonization.
• Conduct thorough analysis to understand the impact of different practices.
• Create and execute implementation plans for transitioning to harmonized processes including training.
• Drive and embed a preventive action culture via root cause investigation, using risk assessments in collaboration with Engineering and Operations.
• Maintain compliant and state‑of‑the‑art control processes, equipment and methods.
• Participate in steering committees and project teams which originate from supplier, customer and manufacturing facilities.
• Support and at times lead business initiatives such as harmonization of control strategies, implementation of system enhancements, and execution of strategic initiatives like Annex 1.
• Lead customer projects related to strategic initiatives like contamination reduction program / Annex 1.
• Working with the QA Managers, develop a strategy within the advanced manufacturing sites to embrace trending and tracking rules against selected process parameters, quality attribute and variable data.
• Enhance customer relationships by improving quality performance across key indicators.
• Strengthen the Quality Culture of the advanced manufacturing sites by leading cross‑functional Quality Culture assessments at the sites and support site SLT by establishing appropriate action plans.
• Provide guidance to the sites in case of major quality events…