Quality Systems Supervisor

Kinovate Life Sciences, Inc. established in 2004 in Oceanside, California. A wholly owned subsidiary of Nitto Denko Corporation (www.nitto.com), Kinovate was spun-off from Oceanside, CA based R&D facility Nitto Denko Technical Corp (www.ndtcorp.com) with a mission to provide the highest quality materials to niche life science markets worldwide.

Since its inception, Kinovate has grown to become the market leader in solid support in the oligonucleotide synthesis field. We are bringing the most creative minds in science and technology to develop medical discoveries and breakthroughs. Our customers are well-known in the biotechnology industry. We are in a growth phase within ISO work environment and leading towards a GMP Certification. KLS is seeking extraordinary people to join the team. KLS is proud to be an equal employment opportunity employer.

Why Work Here Great place to work. Small subsidiary of large international company headquartered in Japan. Generous discretionary bonuses. Health, dental, vision, life, and disability insurance effective from date of hire. Additional benefits include 401(k), 3 weeks vacation in your first year, 12 paid yearly holidays, 5 paid sick days, tuition reimbursement and more.

JOB SUMMARY :

Under strategic leadership, sustain the improvement of the Quality Management Systems (QMS) and manage the development of quality assurance & systems staff. Utilize the following industry standards to drive high-quality products : Current Good Manufacturing Practice (cGMP), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), and International Organization for Standardization (ISO). Facilitate employee relations issues including coaching, mentoring, and disciplining including performance evaluation of employees. Provide strong leadership to motivate, guide and inspire employees to meet the organization’s business objectives with production.Lead the implementation phase of MasterControl, ensuring successful implementation, and post-implementation management.

ESSENTIAL DUTIES and / or RESPONSIBILITIES :

• Partners with leadership to develop the Quality Management System (QMS) and ensure it is compliant with relevant regulations, including ISO 9001, 21 CFR Part 210 and 211, ICH, and other applicable national and international regulatory guidelines.Ensure the QMS always remains in an auditable state.
• Leads the transition of QMS programs, such as Document Control, Training, Quality Events (Deviation, CAPA, Change Control), Audits and Supplier Qualification transition into Master Control, and serves as the System Administrator.
• Leads post-implementation management of MasterControl, including, but not limited to, system optimization, performing troubleshooting support, managing software updates, and continuously improving system functionality to meet evolving regulatory needs.
• Oversees the daily operations of the QMS, ensuring it runs efficiently and in compliance with quality standards. This includes managing critical quality systems processes such as Document Control, Training, Customer questionnaires and tracking and reporting key metrics for Quality Events, including Deviation, CAPA, Change, Control, Audit, and Supplier Management.
• Manages the execution of internal and external audits, ensuring the company is always prepared for audits. Ensures compliance to the internal audit program. Lead audit preparations by ensuring that quality management system documentation is up-to-date and readily available for inspections; including external inspections, serving as the primary point of contact for inspectors, and provide the necessary documentation to support the audit process. Manage post-audit responses and tracking of audit action items.
• Ensures proper documentation and records management in compliance with relevant requirements, including batch production records, testing records, and compliance documentation. Monitor the retention and archiving of records in compliance with requirements to ensure traceability and access during audits.
• Contributes to the continuous improvement initiatives related to the QMS, collaborating with cross-functional teams to optimize quality processes. Analyze quality data and metrics to identify trends, root causes, and areas for process improvement within manufacturing and quality control activities.
• Develops standard operations and other quality documents related to QMS and ensure all documents meet regulatory requirements and internal standards.
• Supervises and develop a team of Quality Systems specialists, providing guidance, training, and support to ensure compliance with regulatory standards and best practices.
• Mentors and develop a team of Quality Systems specialists, fostering an environment of accountability and growth. Ensure cross-functional collaboration and provide effective leadership managing the QMS processes and ensures effective employee relations.
• Directs training initiatives to ensure that team members are adequately prepared to handle QMS functions and sustain a flexible workforce.
• Fosters a culture of continuous improvement, supporting staff development and efficiency improvements within the quality systems team.
• Conducts performance evaluations of direct reports.Institutes timely corrective actions and interfaces with Leadership and HR in developing disciplinary actions up to and including terminations.
• Administers time-keeping functions to track absenteeism; approves timecards on a bi-weekly basis.
• Other duties as assigned.

SUPERVISORY RESPONSIBILITES :

MINIMUM EDUCATION and / or EXPERIENCE :

KNOWLEDGE, SKILLS and / or ABILITIES :

CERTIFICATES and / or LICENSES :

PHYSICAL DEMANDS and / or WORK ENVIRONMENT : (Typical physical demands and the work environment characteristics an employee must meet and encounter while performing the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)