Sr. Supervisor, Quality Systems

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 Systems Supervisor plays a critical role in driving quality and compliance across the organization, directly impacting the success of our CDMO operations. By leading key quality systems, particularly CAPA management, audit hosting, supplier quality oversight, and annual product quality reviews, this individual ensures continuous improvement and regulatory readiness. Their leadership of the document systems team supports robust document control and archival processes, helping maintain compliance in both pharmaceutical and medical device manufacturing. This role not only safeguards product integrity and patient safety but also strengthens client trust and operational excellence. Responsibilities: Lead the CAPA system, ensuring timely investigations, root cause analysis and implementation of effective corrective/preventive actions. Manage internal and external audits, including hosting, documentation preparation, and response coordination. Oversee supplier quality processes, including qualification, performance monitoring, and issue resolution. Direct the preparation and completion of Annual Product Quality Reviews (APQR) in compliance with regulatory standards. Supervise document control and archival systems, ensuring accuracy, compliance, and timely updates. Track and report quality system metrics, including CAPA effectiveness, audit findings, and supplier performance Develop and deliver training programs for the quality systems team on procedures and regulatory requirements. Drive continuous improvement initiatives to enhance quality system efficiency and promote a culture of compliance Ensure all quality systems meet current regulatory requirements (FDA, EU, PIC/S, Health Canada, etc.) Collaborate cross-functionally with departments such as Manufacturing, R & D, and Supply Chain to support quality across the product life cycle. Perform additional tasks as needed to support the overall quality management system. Qualifications: Basic Qualifications: Bachelor's degree in scientific discipline (Biology, Chemistry, engineering, or related field). At least 6 years of experience in pharmaceutical or medical device manufacturing, with at least three years in a leadership or supervisory role overseeing quality systems. Strong knowledge of cGMP regulations, 21 CFR Part 820, 21 CFR Part 210, 21 CFR Part 211 and ISO 13485, and experience in managing regulatory inspections and customer audits. Proven experience in CAPA management, including effective root cause analysis and implementation of corrective and preventive actions. Experience in managing supplier quality programs, including supplier qualifications, audits and performance monitoring. Strong understanding of document control and archival systems in a regulated environment. Ability to develop and maintain metrics and reporting systems to assess the performance and effectiveness of quality systems. Excellent interpersonal and communication skills, with the ability to interact effectively with cross-functional teams, suppliers and regulatory bodies. Strong organizational and leadership skills, with the ability to prioritize tasks and manage multiple projects simultaneously. Ability to work independently and as part of a team, demonstrating adaptability and a proactive approach to problem-solving. Familiarity with electronic quality management systems (eQMS) and other relevant software platforms. The employee must wear all required safety equipment and perform assigned work in a safe manner. Employees must follow all GMP and safety procedures within the department.   Physical Requirements: Regular use of hands for documentation, equipment operation, and material handling Extended periods of standing and walking Ability to lift/move Full range of vision capabilities (close, distance, color, peripheral, depth) Must wear required PPE and follow cGMP/safety procedures Lift heavy equipment up to 60 pounds occasionally, climb ladders, and work in confined spaces.   # LI-Onsite