Director of Quality

Job Summary Lead the development and execution of the quality assurance strategy at the West Indianapolis site. Oversee quality systems, compliance, assurance, control, and continuous improvement to meet regulatory requirements, corporate standards, and customer expectations. Essential Duties and Responsibilities Serve as a key member of the Site Leadership Team, contributing to strategic planning and site objectives. Direct and lead the Quality function for combination medicinal products, investigational medicinal products (IMP), medical device products/components. Act as Head of Quality Control, Head of Quality, and Official Correspondent 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. Lead Quality Assurance, Quality Engineering, Quality Systems, and Quality Program teams. Maintain readiness for regulatory inspections and customer audits; lead site responses and remediation plans. Oversee implementation and maintenance of the Quality Management System (QMS). Build and maintain strong relationships with customers, ensuring alignment with Quality Agreements. Represent QA in customer steering committees and business reviews, chairing meetings on quality standards. Manage customer satisfaction processes, monitor performance and drive corrective and preventive actions. Establish and monitor quality KPIs, providing regular progress updates to senior management. Manage the quality departmental budget and final product disposition/batch release decisions. Act as Management Representative and collaborate with global quality teams. Inspire a culture of innovation and quality excellence, embedding it into the organization’s DNA. Lead by example, support talent development, and champion employee engagement. Additional Responsibilities Contribute to ramping up a state‑of‑the‑art manufacturing facility from the ground up. Embrace change and innovation while launching new operations at record speed. Work independently, support teammates, and handle evolving priorities. Take pride in producing high‑quality products that improve patient lives worldwide. Live West’s core values of integrity, teamwork and accountability. Show initiative and ownership in areas beyond formal responsibilities. Education and Experience Education Bachelor’s Degree in Quality, Engineering, Life Sciences or equivalent experience. Master’s degree preferred. Work Experience 10+ years of quality/regulatory management in medical device, pharmaceutical packaging or combination product manufacturing. Proven experience with ISO 13485, FDA 21 CFR Part 820, 210/211, Part 4 and other regulatory frameworks. Track record of implementing process improvements and ensuring regulatory compliance. Preferred Knowledge, Skills, and Abilities In‑depth knowledge of medical device and pharmaceutical regulations, cGMP, ICH guidelines. Strong leadership and cross‑functional team management. Excellent written and verbal communication. Strong analytical and problem‑solving skills. Adaptability to changing regulatory landscapes. Adherence to ethical standards and integrity. Additional Requirements Effective interpersonal and technical writing skills. Ability to manage multiple third‑party audits and regulatory queries. Strong organizational and prioritization skills. Self‑motivated with ability to work independently and in a team environment. Travel Requirements Up to 10% – 26 business days per year. Physical Requirements Sedentary with occasional lifting of up to 10 lbs (4 kg). Primarily sitting work. West is an equal‑opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If special accommodation is required to apply, please email View email address on click.appcast.io. Where permitted by law, acceptance is contingent upon successful background and drug screening. #J-18808-Ljbffr