Director of Quality

Description

This is an onsite position requiring the team member to be onsite 5 days a 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.

West is expanding in Indiana with a cutting‑edge manufacturing facility designed to drive innovation, quality, and operational excellence. We’re seeking forward‑thinking professionals who excel in fast‑paced settings, lead with integrity, and value teamwork and continuous improvement. If you’re energized by building something new, fostering collaboration, and driving impact in a purpose‑driven industry, this is your opportunity to help shape the future of West and accelerate our mission to improve patient lives globally.

In this role, you will lead the development and execution of the quality assurance strategy for the West, Indiana site. You will oversee all aspects of quality systems, compliance, assurance, control, and continuous improvement to ensure adherence to regulatory requirements, corporate quality standards, and customer expectations.

As an integral member of the Site Leadership Team, you will align quality initiatives with business objectives and operational performance goals. Your responsibilities include oversight of drug packaging operations, combination product manufacturing, and investigational medicinal products (IMP), while fostering a culture of quality, continuous improvement, and operational excellence.

This position demands transformational leadership on a rapidly growing campus recognized as a center of excellence with significant expansion plans. Success in this role requires strong engagement with both local and global leaders to deliver innovative, compliant, and scalable quality solutions.

Although much of the work performed in this role impacts the local team, this role also includes the opportunity to provide input into enterprise quality system initiatives which includes but is not limited to the quality system initiatives which possess global impact.

• Serve as a key member of the Site Leadership Team, actively contributing to strategic planning, achievement of site objectives and decisions to ensure patient safety and product quality.
• Direct and lead the Quality function for combination medicinal products, investigational medicinal products (IMP), and medical device products/components molded, assembled, and packaged at the Indiana site.
• Act as Head of Quality Control, Head of Quality, and Official Correspondent in accordance with US and regional legislation for all government agency authorizations, communications, and registrations.
• Develop and execute the site quality strategy, ensuring alignment with corporate objectives and regulatory requirements.
• Ensure site adherence to GMP, ISO 13485, FDA, EMA, and other applicable regulations for medical device, drug packaging and combination products.
• Direct Quality Assurance, Quality Engineering, Quality Systems, and Quality Program teams, ensuring strong engagement with internal stakeholders (Program Management, Operations, Engineering, Supply Chain, Continuous Improvement etc.).
• Maintain readiness for regulatory inspections and customer audits; lead site responses and remediation plans.
• O…