Director, Quality Operations

Our Work MattersAt Kindeva we make products that save lives ensuring better health and well-being for patients around the Impact You Will MakeThe 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 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 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 : Quality LeadershipLead the daily execution of Quality Assurance and Quality System activities supporting commercial manufacturing packaging testing and release closely with Manufacturing Engineering and Supply Chain to ensure quality support is aligned with production schedules and business quality systems and processes support efficient operations while maintaining compliance with applicable regulatory a culture of quality accountability continuous improvement and operational excellence throughout the quality resources departmental budgets staffing levels and priorities across multiple commercial client programs while ensuring adherence to quality agreements and regulatory departmental goals and objectives and make independent decisions regarding personnel workload distribution quality priorities and operational Assurance and Quality SystemsProvide leadership and oversight for batch record review and product disposition leadership and oversight for customer complaint the quality documentation timely and compliant batch release decisions in accordance with cGMP requirements quality agreements and customer execution of deviation investigations CAPAs change controls complaints and risk quality events are investigated thoroughly root causes are identified and effective corrective actions are quality system performance metrics and drive improvements in effectiveness timeliness and Quality SupportProvide quality leadership and oversight for production floor adequate QA presence and support for manufacturing operations qualification activities technology transfers and validation as escalation point for quality-related manufacturing issues and support effective resolution of operational with operations leadership to identify and implement process improvements that enhance quality reliability and and Inspection ReadinessMaintain a state of inspection readiness across all quality assurance quality systems and manufacturing regulatory inspections customer audits and internal audits by ensuring timely preparation execution and follow-up compliance with applicable FDA EMA ICH ISO 13485 and combination product emerging compliance risks and implement proactive mitigation ImprovementDrive simplification standardization and optimization of quality quality metrics trend analysis and operational performance indicators to identify areas for initiatives that improve right-first-time performance reduce quality-related disruptions and enhance manufacturing implementation and continuous improvement of electronic quality systems and digital quality LeadershipLead coach and develop Quality Assurance and Quality Systems personnel including managers supervisors and individual contributorsDirect 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 organizational capability through talent development succession planning and employee engagement a culture of collaboration accountability and continuous future quality leaders through mentoring coaching and structured development ManagementResponsible for the overall management of the Quality Assurance and Quality Systems and indirectly supervise managers supervisors and professional authority over hiring performance management compensation recommendations promotion decisions disciplinary actions and termination effective utilization of personnel and department resources to achieve business and compliance and ExperienceBachelors 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 experience leading Quality Operations or Quality Assurance organizations supporting commercial supporting regulatory inspections and customer audits with successful within a contract development and manufacturing organization (CDMO/CDMO) environment strongly 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 knowledge of cGMP regulations quality systems risk management and pharmaceutical manufacturing ability to lead quality operations within a fast-paced commercial manufacturing investigation problem-solving and decision-making to balance compliance requirements with operational leadership communication and stakeholder management implementing process improvements and driving organizational understanding of manufacturing operations and the application of quality principles to support reliable product supply.#LI-Onsite#JJ