Director, Quality Operations

Our Work Matters At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make The Quality Director is responsible for leading both the Quality Assurance and Quality Systems groups at the Northridge facility. The primary duty of this position is the management of the Quality Assurance and Quality Systems functions, including directing the work of subordinate managers, supervisors, and employees, and exercising independent judgment on matters of significance affecting product quality, compliance, and business operations. In this role, the Director will ensure quality systems, manufacturing support activities, and batch disposition processes operate effectively and in compliance with cGMP requirements. Additionally, this role provides leadership for site Quality Assurance operations and serves as a key partner to Manufacturing, Engineering, and Supply Chain to ensure reliable commercial production while maintaining the highest standards of compliance and patient safety. The Quality Director drives operational excellence across quality processes and develops a high-performing quality organization capable of supporting a complex multi-product contract manufacturing environment focused on transdermal and inhalation combination drug products. Responsibilities: Quality Leadership Lead the daily execution of Quality Assurance and Quality System activities supporting commercial manufacturing, packaging, testing, and release activities. Partner closely with Manufacturing, Engineering, and Supply Chain to ensure quality support is aligned with production schedules and business priorities. Ensure quality systems and processes support efficient operations while maintaining compliance with applicable regulatory requirements. Drive a culture of quality, accountability, continuous improvement, and operational excellence throughout the organization. Manage quality resources, departmental budgets, staffing levels, and priorities across multiple commercial client programs while ensuring adherence to quality agreements and regulatory commitments. Establish departmental goals and objectives and make independent decisions regarding personnel, workload distribution, quality priorities, and operational strategy. Quality Assurance and Quality Systems Provide leadership and oversight for batch record review and product disposition activities. Provide leadership and oversight for customer complaint activities. Oversee the quality documentation process. Ensure timely and compliant batch release decisions in accordance with cGMP requirements, quality agreements, and customer expectations. Oversee execution of deviation investigations, CAPAs, change controls, complaints, and risk assessments. Ensure quality events are investigated thoroughly, root causes are identified, and effective corrective actions are implemented. Monitor quality system performance metrics and drive improvements in effectiveness, timeliness, and compliance. Manufacturing Quality Support Provide quality leadership and oversight for production floor activities. Ensure adequate QA presence and support for manufacturing operations, qualification activities, technology transfers, and validation programs. Serve as escalation point for quality-related manufacturing issues and support effective resolution of operational challenges. Partner with operations leadership to identify and implement process improvements that enhance quality, reliability, and efficiency. Compliance and Inspection Readiness Maintain a state of inspection readiness across all quality assurance, quality systems, and manufacturing operations. Support regulatory inspections, customer audits, and internal audits by ensuring timely preparation, execution, and follow-up activities. Ensure compliance with applicable FDA, EMA, ICH, ISO 13485, and combination product requirements. Identify emerging compliance risks and implement proactive mitigation strategies. Continuous Improvement Drive simplification, standardization, and optimization of quality processes. Leverage quality metrics, trend analysis, and operational performance indicators to identify areas for improvement. Champion initiatives that improve right-first-time performance, reduce quality-related disruptions, and enhance manufacturing throughput. Support implementation and continuous improvement of electronic quality systems and digital quality initiatives. People Leadership Lead, coach, and develop Quality Assurance and Quality Systems personnel, including managers, supervisors, and individual contributors Direct the work of two or more full-time employees and oversee departmental staffing and resource allocation. Interview, hire, assess performance, recommend promotions, administer corrective action, and make recommendations regarding employment status changes, which are given substantial weight. Build organizational capability through talent development, succession planning, and employee engagement initiatives. Promote a culture of collaboration, accountability, and continuous learning. Develop future quality leaders through mentoring, coaching, and structured development opportunities. Organizational Management Responsible for the overall management of the Quality Assurance and Quality Systems departments. Directly and indirectly supervise managers, supervisors, and professional staff. Exercise authority over hiring, performance management, compensation recommendations, promotion decisions, disciplinary actions, and termination recommendations. Ensures effective utilization of personnel and department resources to achieve business and compliance objectives. Education and Experience Bachelor's degree in Life Sciences, Pharmacy, Engineering, or related discipline (advanced degree preferred). 15 years of progressive GMP quality experience within pharmaceutical, biologics, medical device, or combination product manufacturing environments. Demonstrated experience leading Quality Operations or Quality Assurance organizations supporting commercial manufacturing. Experience supporting regulatory inspections and customer audits with successful outcomes. Experience within a contract development and manufacturing organization (CDMO/CDMO) environment strongly preferred. Experience supporting combination products and working knowledge of applicable regulatory requirements including 21 CFR Part 4, 21 CFR Parts 210/211, 21 CFR Part 820, and ISO 13485 preferred. Skills Strong knowledge of cGMP regulations, quality systems, risk management, and pharmaceutical manufacturing processes. Demonstrated ability to lead quality operations within a fast-paced commercial manufacturing environment. Strong investigation, problem-solving, and decision-making skills. Ability to balance compliance requirements with operational objectives. Excellent leadership, communication, and stakeholder management capabilities. Experience implementing process improvements and driving organizational change. Strong understanding of manufacturing operations and the application of quality principles to support reliable product supply. #J-18808-Ljbffr Kindeva