The Human Applications Laboratory (HAL) Quality Manager is responsible for leading the development, implementation, and ongoing maturation of the Quality Management System (QMS) supporting GMP and GLP operations for cellular immunotherapy products, including immune cells, within the Human Applications Laboratory (HAL). This position will establish the quality infrastructure necessary to support compliant laboratory operations by developing quality processes, Standard Operating Procedures (SOPs), Quality Control (QC) programs, controlled documentation, training programs, and quality records in accordance with applicable FDA regulations, current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and internal quality standards.
Responsibilities:
Quality Management System (QMS)
· Lead the development, implementation, maintenance, and continuous improvement of the Human Applications Laboratory (HAL) Quality Management System (QMS) supporting GLP and GMP operations.
· Develop, implement, and monitor quality policies, procedures, forms, and work instructions to ensure compliance with applicable regulatory requirements and industry standards.
· Ensure compliance with Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), Good Tissue Practices (GTP), Good Documentation Practices (GDP), and other applicable regulations and accreditation standards.
· Partner with laboratory leadership to establish quality objectives, quality metrics, and continuous improvement initiatives.
Document Control and Quality Records
· Develop, review, approve, revise, and maintain SOPs, batch records, controlled forms, specifications, validation documentation, and other quality records.
· Ensure timely and accurate completion, review, and retention of GMP and GLP documentation, including laboratory records, batch records, equipment logs, training records, QC documentation, and quality reports.
· Maintain document control processes and ensure version control of all controlled documents.
Quality Assurance and Quality Control
· Support the QC Specialist in the development of and oversee the Quality Control (QC) programs for laboratory operations and cellular therapy manufacturing.
· Review and approve analytical testing, reagent verification, equipment qualification, process validation, environmental monitoring, and batch documentation.
· Review and approve material receipt, inspection, release, Certificates of Analysis (COAs), Safety Data Sheets (SDS), and product disposition.
· Monitor quality performance through quality indicators, QC charts, monthly quality monitors, and trend analysis.
Quality Systems
· Manage deviations, nonconformances, investigations, Root Cause Analyses (RCA), Corrective and Preventive Actions (CAPA), Change Control, and risk assessments.
· Perform trend analysis of quality data to identify recurring issues, systemic risks, and opportunities for process improvement.
· Prepare quality metrics, management reports, and quality summaries for leadership review.
· Maintain inspection readiness and facilitate internal, customer, vendor, and regulatory inspections.
Supplier and Regulatory Quality
· Develop and maintain supplier qualification and supplier monitoring programs.
· Investigate customer complaints and coordinate appropriate quality actions.
· Support regulatory inspections, accreditation activities, and customer audits, including responses to findings and implementation of corrective actions.
· Ensure compliance with FDA regulations, AABB Standards, FACT Standards, and other applicable regulatory requirements.
Training and Personnel Qualification
· Develop and maintain quality training, orientation, competency assessment, and personnel qualification programs.
· Ensure personnel training and competency records remain current and compliant.
· Support qualification of personnel for GMP activities, including aseptic processing, as applicable.
Laboratory Operations Support
· Collaborate with the HAL team to ensure GMP processes for the isolation, processing, expansion, characterization, and storage of immune cells are compliant.
· Support development, validation, qualification, and continuous improvement of laboratory processes, equipment, biobanking and manufacturing workflows.
· Support FDA IND-enabling activities and Phase I clinical trial manufacturing through quality oversight and documentation review.
Technical Laboratory Responsibilities
· Oversee quality review of bioanalytical testing, including flow cytometry, cell counting, microscopy, immunomagnetic cell selection, fluorescence-activated cell sorting (FACS), and related laboratory techniques, as required.
· Ensure appropriate equipment qualification, calibration, maintenance, and documentation.
Operational Support
Perform additional Quality duties and special projects as assigned.
Qualifications:
- Minimum of 7 years of progressive experience in regulated quality systems.
- Demonstrated experience developing and implementing GMP Quality Management Systems.
- Cell therapy or biologics experience.
- Startup GMP facility experience.
- Experience supporting FDA inspections.
- Experience with deviations, CAPA, Change Control, document control, risk management, training, supplier qualification, and internal auditing.
- FACT or AABB experience preferred.
- Minimum of 3 years of leadership experience supervising quality personnel. Supervisory required, management preferred
Education Requirements:
- Bachelor's degree in a scientific, engineering, or related discipline required.
- Preferred: ASQ certification
Work Location:
Work Remotely:
Job Type: Full-time
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Application Question(s):
- Are you willing to undergo a background check, in accordance with local law/regulations?
- Are you willing to take a drug test, in accordance with local law/regulations?
- Will you now or in the future require employer-sponsored work authorization (e.g., H-1B visa sponsorship) to work in the United States?
Education:
Experience:
- supervisory: 3 years (Required)
- regulated quality systems: 7 years (Required)
License/Certification:
- ASQ certification (Preferred)
Ability to Commute:
- Huntersville, NC 28078 (Required)
Work Location: In person
