Head of Quality Systems (Cell/Gene Therapy)
Location: Raleigh, NC
HireMinds has partnered with a team that expanding cell/gene therapy manufacturing operations in Raleigh, North Carolina. In this exciting role to lead Quality we are seeking a dynamic leader and Head of Quality Systems. As the Head of Quality Systems you will be instrumental in designing, implementing, and overseeing the quality management function and testing operations for clients across the United States. You’ll be successful in this role in providing the team strategic leadership to ensure the delivery of high-quality and GxP-compliant testing services in alignment with organizational goals. Reach out to the HireMinds today and apply to learn more about this exciting role. Relocation will be considered for qualified candidates.
You’ll Be Responsible For:
Strategic Leadership: Lead the design, implementation, and oversight of the quality management function for US Cell/Gene therapy testing and quality operations.
Provide strategic leadership and oversight of laboratory and quality systems organization to deliver high-quality and GxP-compliant testing services for clients.
Team Development: Build and lead an empowered team of quality and regulatory experts, overseeing tools, business processes, and procedures supporting cell-based bioassay, cell & gene therapy, and virology testing.
Quality Assurance: Ensure quality processes, procedures, and tools are fit for purpose, GxP compliant, and support analytical timelines and future commercial launch needs.
Compliance Adherence: Ensure strict site adherence to regulatory requirements, including implementing SOP’s, US FDA Good Laboratory Practices (GLP), and current Good Manufacturing Practices (cGMP) under preclinical to clinical grade testing.
Quality & Regulatory:
- Ensure compliance with relevant GxP regulations, conducting assessments against FDA, EMA, and ICH standards.
- Design and deploy the overall quality management system and policies consistent with GMP/GLP principles and the organization’s mission.
Document Management (QMS) System: Implement a robust quality document control system to manage GxP-related documents, ensuring compliance with standards.
- Ensure proper training in development of a comprehensive GxP training program for all employees, with periodic updates to curriculum and standards.
- Risk Management: Conduct risk assessments for processes, laboratory operations, and suppliers to identify and mitigate potential risks.
- Supplier Management: Establish a process for qualifying and monitoring suppliers to ensure the quality of incoming materials.
- Validation and Qualification: Develop a process validation plan for critical manufacturing processes, implementing a program for qualifying and maintaining equipment.
- Internal Audits: Establish a regular schedule for internal audits to assess GxP compliance, implementing a robust CAPA system and serve as a key contact with agencies.
- Quality Metrics: Establish key performance indicators (KPIs) to measure the effectiveness of the quality management system.
- Documentation of Incidents and Deviations: Develop a system for reporting and documenting incidents, deviations, and out-of-specification results.
- External Inspections: Develop a plan for handling external inspections by regulatory authorities, conducting mock inspections to prepare staff.
- Communication and Transparency: Establish effective communication channels to ensure awareness of GxP requirements among all employees.
- Documentation of Quality Events: Ensure prompt implementation of corrective actions in response to quality events, maintaining detailed records of investigations.
- Data Integrity: Develop and enforce policies to ensure the integrity of data generated during testing processes.
- Periodic Management Review: Conduct regular management review meetings to assess the effectiveness of the quality management system.
- Documentation of Complaints and Recalls: Develop procedures for handling customer complaints and initiating product recalls if necessary.
- Document Retention and Archiving: Develop policies for the retention and archiving of GxP-related documents, ensuring compliance with regulatory requirements.
- Continuous Review: Regularly review the quality management system to ensure its ongoing suitability, adequacy, and effectiveness.
Key Experience and Requirements:
- BS/MS/PhD degree in a Pharmaceutical Manufacturing/Engineering, Analytical Chemistry, Chemistry, or related Quality fields.
- 10+ years of experience in the Pharma/Biopharmaceutical industry with experience in cell/gene therapy product development, analytical testing, or manufacturing space.
- Extensive quality systems management experience with a proven record of building and overseeing quality systems in a GxP regulated environment.
- Experience in a cell/gene therapy product development, manufacturing, or laboratory testing environment and with US and EU Regulations.
- Experience with a variety of analytical testing assays including cell-based assays, cell-gene therapy, molecular biology, and virology.
- Strong knowledge of GxP regulations and their application to non-clinical, clinical, and commercial products.
- Agile leader with effective communication skills, adept at managing ambiguity, removing barriers, and overcoming resistance.
- Experience in Quality site design for new manufacturing/testing labs is ideal.