Director of Quality

Director of Quality

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.

Essential Duties and Responsibilities

• 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.
• Oversee the implementation and maintenance of the Quality Management System (QMS)
• Build and maintain strong relationships with customers, ensuring alignment and compliance with all customer Quality Agreements, specifications, and contractual obligations.
• Represent QA in customer steering committees and business reviews, chairing meetings on Quality standards and expectations.
• Manage customer satisfaction processes, monitor performance against agreed standards, and drive corrective and preventive improvements where discrepancies are identified
• 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.
• Act as Management Representative, ensuring implementation and integrity of the Quality System.
• Collaborate with global quality teams to harmonize standards and share best practices.
• Inspire a culture of innovation and quality excellence, embedding it into the organization's DNA.
• Lead by example, setting high standards for employee engagement and communication.
• Champion talent development, supporting local and global programs.
• Perform other duties as assigned based on business needs.

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.

Why Join Us:

• Adaptability and
  
  Collaboration:
  
  Thrive in a fast-paced, evolving environment where priorities shift; embrace change, ambiguity, and innovation while supporting cross-functional initiatives.
• Positive and Proactive Mindset:
  Bring a can-do attitude, show initiative, and take ownership—even in areas beyond formal responsibilities.
• Teamwork and…