Associate Director, Quality Assurance

Kincell is a technology-forward contract development and manufacturing organization (CDMO) that streamlines analytical development, process development, CMC consulting and early-stage GMP cell therapy manufacturing.

Our focus is on developing and manufacturing immune cell therapies, including autologous and allogeneic CAR-T, CAR-NK, and CAR-M programs.

For more information, please visit our website at www.kincellbio.com.

Kincell is seeking a highly motivated Associate Director who will be a key contributor to a dynamic and collaborative Quality Assurance team.

The Associate Director of Quality Assurance is responsible and accountable for all aspects of the Quality Assurance.  Develops, implements, and maintains an effective Quality Management System in accordance with appropriate regulations and standards. 

The Associate Director of Quality Assurance is responsible and accountable for all aspects of the Quality Management System (QMS), and the Product Data Group (PDG). The Associate Director will offer guidance and support to personnel in a cGMP manufacturing environment, either self or through direct reports. Possesses and applies a broad knowledge of Quality principles, practices, and procedures with an astute ability to rank priorities in order of importance and feel comfortable making decisions on quality matters. Manages and supports a variety of processes including Document Control process and Change Control process. Responsible for material and Finished Goods Disposition and Release. Must be able to lead and work with cross-functional teams and track projects to completion. Requires experience in cGMP sterile manufacturing environment plus demonstrated familiarity with standard quality concepts, practices, and procedures.

Essential Duties and Responsibilities

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.

• Supervise staff including hiring, training, evaluating performance, and performance management.
• Ensure all employees have the necessary training, tools, information and materials to properly and safely perform their job responsibilities.
• Oversees and supervises broad areas of operations, such as reviewing QC testing, scheduling of work, provide basic technical and quality support to staff members and clients.
• Assign training and monitor and review training completion to ensure personnel are properly trained and capable of completing their assigned tasks.
• Lead Deviation, CAPA and Change Control, Supplier Quality, Customer Complain Document Control and Audit Management programs.
• Act as the main interface between Kincell Bio Quality and client Quality; ensures the status and progress of projects is on target and easily visible to Kincell Leadership.
• Demonstrated attention to detail and ALCOA standards implementation.
• Participate in writing, reviewing and approving Standard Operating Procedures, Reports, etc.
• Overseeing or reviewing, completing and processing of process documentation.
• Oversee budgets and goals for the group on an annual basis.
• Supervise and guide internal and external audits of various departments/processes.
• Oversee and perform QA activities, including processing change requests, manufacturing records, and other documents.
• Assist with developing or participating in department or cross-functional project or program objectives, which include proposed budgets, timelines, materials, personnel and other project requirements, receives direction and presents information updates to leadership.
• Assures Kincell is compliant with regulatory expectations.
• Responsible for completing the disposition of all in-process and finished products, ensuring compliance with all applicable regulations.
• Addresses audit observations or recommendations and implement corrective/preventive actions as needed.
• Serve as the lead auditor for client inspections.
• Preparation, execution and maintenance of quality agreements.
• Ensure compliance with GMP, EU, FDA, OSHA, and all other regulatory requirements in accordance with company policy.
• Adhere to company safety requirements. Maintains a safe and healthy work environment by establishing and enforcing organizational safety standards and adhering to legal regulations.
• Other duties as assigned.

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully