Quality Transformation Lead

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Requisition

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.

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 Transformation Lead will lead transformative global efficiency programs. This position will evaluate process capability within quality, identify waste and redundancy, create business cases to change, and lead the development and deployment of the improvement. Individuals in this position will be change agents that influence enterprise operating models and standards.

• Development of current‑state process maps, problem definition, and measurable improvements.
• Conduct stakeholder analysis and formulate communication plans to create a shared need.
• Assemble a tangible business case and seek funding through standard review process.
• Develop and maintain a multi‑phased project and resource plan.
• Present program status updates to executive champions.
• Lead a cross‑functional process design including risk mitigation, KPIs, user requirements, user acceptance criteria, and standard work.
• Integrate process into existing QMS standards.
• Responsible for assembling a project team, assigning individual responsibilities, identifying appropriate resources needed, and developing schedules to ensure timely completion of project.
• Lead the identification, assessment, monitoring, and closure of project risks throughout the project lifecycle.
• Measure project plans, budget, and resource allocation to deliver solution as expected.
• Create and release training that supports the solution.
• Establish a support network and governance structure to implement and maintain the solution.
• Identify and coordinate with related process changes across the organization to maintain standard enterprise solutions.
• Execute seamless hand‑offs of newly designed process with global process owners and supporting teams.
• All other duties as required.

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

• Bachelor's Degree in a Science related field, Chemistry, Biology, Engineering required or equivalent experience.

• Minimum 5 years in Continuous Improvement / Operational Excellence.
• Minimum 5 years experience in a pharmaceutical or medical device environment; minimum 2 years experience in a Quality role.

• Deep knowledge of quality processes such as CAPA, complaint management, risk management, root cause analysis, statistical sampling plans, FMEA/Fault Tree Analysis, Design Optimization using DOE, Hardware Reliability, Software Reliability, and Design Controls including Design…