Site Head of Quality

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 Site Head of Quality leader who will be a key contributor to a dynamic and collaborative Quality Assurance and Quality Control team.

The Site Head of Quality is responsible and accountable for all aspects of the Site Quality for manufacturing, testing, and release of Cellular Therapy products for clients. The Site Head also has responsibility for the Quality Management System (QMS) and product disposition of products to support customers clinical trials. The Site Head of Quality will offer direct and indirect guidance and support to personnel in a cGMP manufacturing environment. The Site Head of Quality must possess and apply 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. The Site Head of Quality also manages and supports a variety of processes including Document Control and Change Control. The Site Head of Quality is also responsible for incoming material and finished goods disposition and release. The Site Head of Quality must be able to lead and work with cross-functional teams and track projects to completion requiring experience in cGMP 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.

• Lead and oversee the Quality function at the site, ensuring compliance with regulatory requirements and industry standards.
• Be thoroughly knowledgeable of Standard Operating Procedures (SOPs), including but not limited to assay and testing procedures and current Good Manufacturing Practices (cGMPs), and maintain a knowledge base on an ongoing basis.
• Demonstrate knowledge of and teach department procedures and company policies, pay attention to detail in all aspects, and ensure all paperwork is completed accurately, neatly, and fully.
• Prepare, communicate, and manage budgets and goals for the Quality Assurance and Quality Control units.
• Supervise and guide internal audits of various departments/processes.
• Oversee and perform Quality Assurance document control activities, including processing change requests, manufacturing records, and other documents.
• Oversee QA and QC activities including managing project priorities, processing of change requests, collaboration with Engineering & Production and development of process related SOPs, either self or through direct reports.
• Write, revise, review and/or approve SOPs, controlled forms, and related documents to ensure best practices and current operations.
• Responsible for completing the disposition of all in-process and finished products, ensuring compliance with all applicable regulations.
• Address observations or recommendations as well as implement corrective/preventive actions as needed.
• Prepare and approve quality agreements.
• Participate in process improvement teams to provide quality input and direction. Ensure that documentation of improvements is completed and approved as needed.
• Ensure compliance with GMP, 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.
• Manage a team of QA and QC personnel, hiring and developing employees within the Gainesville site departments.
• Establish clear goals and performance expectations for the Quality team, monitoring progress and providing regular feedback and coaching.
• Assign responsibilities, provide feedback and coaching, and take necessary disciplinary actions in oversight of both QA and QC at the site level.
• Collaborate cross-functionally with Manufacturing, Regulatory Affairs, Clinical Operations, and other departments to drive alignment and achieve business objectives.
• Other duties as assigned.
  
  
  
  

Qualifications

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

• BS required, MS preferred in a scientific/technical discipline with 10+ years of experience in a quality leadership position within the biological and/or pharmaceutical industry with specific experience in cell and gene therapy preferred.
• Significant experience supporting functional areas (e.g., PD, Manufacturing, QA, Engineering, EHS) preferred.
• Demonstrated experience with writing/reviewing deviations, laboratory investigations, and OOS investigations. Experience with root cause analysis is a plus.
• Demonstrated experience with regulatory inspections from the FDA, EMA, Health Canada, or other regulatory authorities.
• Solid knowledge of FDA and EMA regulatory requirements for biologics or pharmaceuticals.
• Ability to apply cGMP regulations and international guidelines to all aspects of the position.
• Ability to write reports, business correspondence, and procedure manuals.
• Proven track record of successfully leading Quality initiatives and driving compliance in a regulated manufacturing environment.
• Able to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
• Ability to effectively present information to employees, top management, and/or public groups.
• Strong leadership and people management skills, with the ability to inspire and develop high-performing teams.
• Must be able to assess and utilize software and customized programs to meet QA and QC business needs.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions and levels of the organization.
• Strategic mindset with the ability to translate business objectives into actionable Quality strategies and initiatives.
  
  

Travel Requirements

<10%, as needed between site locations.



Location

• This is a site-based position, and it will require some non-standard working hours, including early morning or late evening.
  
  
  
  

Kincell Bio provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable, federal, state, and local laws. Kincell Bio complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

NOTE TO EMPLOYMENT AGENCIES: Kincell Bio values our relationships with our Recruitment Partners. We will only accept resumes from those partners who have been contracted by a member of our Human Resources team to collaborate with us. We are not responsible for any fees related to resumes that are unsolicited or are received without contract.