Director of Quality

About the role

This is an onsite position requiring the team member to be onsite 5 days a week. The West team is dedicated to improving patient lives, tracing back to our roots in World War 2. We're expanding in Indiana with a cutting-edge manufacturing facility focused on innovation, quality, and operational excellence.

Responsibilities

• Serve as a key member of the Site Leadership Team, contributing to strategic planning and achieving site objectives.
• Lead the Quality function for combination medicinal products, investigational medicinal products (IMP), and medical device products/components.
• 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.
• Direct Quality Assurance, Quality Engineering, Quality Systems, and Quality Program teams, fostering a culture of quality, continuous improvement, and operational excellence.
• Oversee the implementation and maintenance of the Quality Management System (QMS).
• Manage customer satisfaction processes, monitor performance against agreed standards, and drive corrective and preventive improvements.
• Establish and monitor Quality KPIs, providing regular progress updates to senior management.
• Manage the quality departmental budget.
• Accountable for final product disposition and batch release decisions for medical device components, sub-assemblies, and combination products.
• Represent QA in customer steering committees and business reviews.
• Collaborate with global quality teams to harmonize standards and share best practices.

Requirements

• Proven experience in Medical Device, Pharmaceutical Packaging and Combination Products regulations, including ISO13485, US FDA Regulations -21 CFR Part 820, 210/211 and Part 4.
• Minimum of 10 years of Quality/ Regulatory management in process-based manufacturing for the medical device and/or pharmaceutical industry.
• Experience in regulatory compliance management, including familiarity with FDA and other regulatory agency requirements.
• Proven track record of implementing process improvements and ensuring compliance with regulatory standards.

Qualifications

• Bachelor’s Degree in Quality, Engineering, Life Sciences or equivalent experience required.
• Master’s degree preferred.

Skills and Abilities

• Regulatory Skills: In-depth knowledge of medical device and pharmaceutical regulations and guidelines, including cGMP, ICH guidelines, and other relevant regulatory requirements.
• Leadership Skills: Strong leadership and management skills with the ability to lead cross-functional teams, drive initiatives, and influence stakeholders at all levels of the organization.
• Communication Skills: Excellent communication skills, both written and verbal, with the ability to effectively communicate requirements and strategies to diverse audiences.
• Analytical Skills: Strong analytical and problem-solving skills, with the ability to analyze complex problems, identify root causes, and develop effective solutions.
• Adaptability: Flexibility and adaptability to navigate changing regulatory landscapes and business priorities.
• Ethical Standards: Adherence to ethical standards and integrity in dealing with regulatory agencies, colleagues, and stakeholders.

Additional Responsibilities

• Bring a positive, can-do attitude every day as we build and grow together.
• Contribute to ramping up a state-of-the-art manufacturing facility from the ground up.
• Embrace change and innovation as we launch new operations at record speed.
• Work hard, stay flexible, and support your teammates to achieve shared goals.
• Take pride in producing high-quality products that improve patient lives worldwide.
• Live West’s core values of integrity, teamwork, and accountability in everything you do.
• Be part of a culture that celebrates learning, problem-solving, and continuous improvement.
• Show initiative and ownership while helping shape a safe, efficient, and high-performing workplace.
• Grow your career and skillset in a dynamic, innovative environment where your contributions truly matter.
• Work independently and take initiative in areas that may not be formally assigned to you.
• Thrive in ambiguity and see change as an opportunity rather than a challenge.
• Work in an evolving fast-paced environment where priorities shift, and new opportunities emerge regularly.