Director of Quality Location:

Seymour, Indiana Area Schedule:

Full-Time | On-Site About the Opportunity A well-established GMP manufacturing organization with operations in the Seymour, Indiana area is seeking an experienced Director of Quality to lead all site Quality functions and provide strategic oversight of the organization's Quality Management System. This confidential opportunity is ideal for an accomplished quality leader with experience in pharmaceutical, nutraceutical, food, cosmetic, or other regulated GMP manufacturing environments. Candidates with a strong regulatory background, proven leadership experience, and a passion for continuous improvement are encouraged to apply. Position Summary The Director of Quality provides strategic and operational leadership for all aspects of Quality Assurance at the site. This position is responsible for ensuring products are manufactured in compliance with applicable regulatory requirements, customer expectations, and company quality standards while fostering a culture of quality throughout the organization. Working closely with executive leadership and cross-functional teams, the Director of Quality oversees the Quality Management System, regulatory compliance, inspection readiness, quality personnel, and continuous improvement initiatives that support operational excellence and customer satisfaction. What You'll Be Doing Quality Leadership & Strategy Provide leadership and direction for all site Quality Assurance functions. Develop, implement, and continuously improve the site's Quality Management System. Establish quality objectives, monitor performance metrics, and communicate results to leadership. Build and promote a culture of quality, accountability, compliance, and continuous improvement across the organization. Partner with senior leadership to align quality initiatives with overall business objectives. Quality Systems & Compliance Provide oversight and continuous improvement of key quality systems, including: Change Control Deviations Corrective and Preventive Actions (CAPA) Supplier Quality Management Customer Complaints Annual Product Reviews (APR) Product Release Document Control Ensure Annual Product Reviews are completed accurately and on schedule. Maintain compliance with cGMP regulations, company procedures, and applicable regulatory requirements. Lead internal quality audits and ensure corrective actions are implemented effectively and on time. Ensure controlled documents are maintained in accordance with company procedures and regulatory expectations. Regulatory & Inspection Readiness Serve as the site's quality leader during regulatory inspections and customer audits. Support inspections conducted by agencies such as the FDA and other regulatory authorities. Provide leadership during customer, supplier, and contract manufacturer audits. Ensure the organization maintains a constant state of inspection readiness. Product Quality & Risk Management Oversee QA inspection activities and final disposition of raw materials and finished products. Lead investigations involving deviations, non-conformances, customer complaints, supplier quality issues, and other quality events. Utilize risk assessment and root cause analysis tools to identify sustainable corrective and preventive actions. Review and approve Change Controls while ensuring implementation activities are completed effectively. Review equipment qualification, validation documentation, and technology transfer activities in partnership with Operations, Engineering, R&D, and Manufacturing. Leadership & Team Development Lead, mentor, and develop the Quality organization through coaching, performance management, and professional development. Build a high-performing team focused on regulatory compliance, customer satisfaction, and continuous improvement. Promote GMP, quality, and regulatory training throughout the organization. Cross-Functional Collaboration Work closely with Operations, Manufacturing, Supply Chain, Engineering, R&D, Regulatory, and executive leadership to ensure quality objectives are achieved. Support business growth by providing quality leadership during new product introductions, process improvements, and operational initiatives. What We're Looking For Required Qualifications Bachelor's degree in Engineering, Chemistry, Biology, Quality Management, or another scientific or technical discipline. Minimum 7-10 years of progressive Quality leadership experience within a regulated GMP manufacturing environment. Minimum 5 years of leadership experience managing Quality teams. Comprehensive knowledge of cGMP regulations and Quality Management Systems.

Demonstrated experience leading:

CAPA Change Control Deviations Root Cause Analysis Risk Assessments Internal Auditing Product Release Experience leading FDA, customer, and regulatory inspections. Excellent technical writing, communication, and presentation skills. Proven ability to influence cross-functional teams and executive leadership. Strong strategic thinking, analytical, and decision-making skills. Preferred Qualifications Experience within pharmaceutical manufacturing, particularly solid dosage manufacturing. Experience in pharmaceutical, nutraceutical, food, cosmetic, or other FDA-regulated GMP manufacturing environments. Experience with equipment qualification, process validation, technology transfer, and quality systems implementation. ASQ certifications or other quality-related professional certifications are a plus. Why Consider This Opportunity? Join an established GMP manufacturer with a strong reputation for quality and regulatory excellence. Serve as the senior Quality leader for the site with the opportunity to influence organizational strategy. Work alongside experienced leadership in a collaborative manufacturing environment. Competitive compensation and comprehensive benefits package. Opportunity to lead meaningful quality initiatives that directly impact business success and customer satisfaction

Pay:

$90,000.00 - $200,000.00 per year

Work Location:

In person