Ensure ongoing facility-wide compliance with 21 CFR Part 1271 (HCT/P and current Good Tissue Practice requirements), 21 CFR Parts 210 and 211 (cGMP requirements), and applicable provisions of 21 CFR Parts 600-680 (biological products)
Develop, implement, and maintain the quality and compliance management system, including SOPs, batch record protocols, deviation management, and CAPA (Corrective and Preventive Action) processes
Oversee laboratory testing procedures and batch release processes, ensuring all documentation meets FDA traceability and accountability standards
Lead internal audits and self-inspections on a recurring schedule; prepare the facility for FDA inspections and respond to any Form 483 observations or warning letters
Review and approve batch records prior to release, verifying identity, potency, purity, and compliance with established specifications
Monitor evolving FDA guidance and regulatory changes affecting regenerative medicine, cell therapy research, and biologics laboratory operations, and advise executive leadership accordingly
Manage donor eligibility, screening, and testing compliance programs required under Part 1271
Conduct compliance risk assessments and identify vulnerabilities across laboratory, testing, and release operations
Develop and deliver ongoing staff training on cGMP/cGTP requirements, SOP adherence, and regulatory updates
Maintain compliance documentation, audit trails, and records required for regulatory reporting and inspection readiness
Serve as primary liaison with FDA and other regulatory bodies during inspections, inquiries, or facility registration matters
Partner with laboratory, quality, and operations leadership to embed compliance into day-to-day workflows without disrupting research timelines
Track and report compliance metrics, audit findings, and remediation status to executive leadership on a regular cadence
Support vendor and supplier qualification from a compliance and documentation standpoint Qualifications
Bachelor's degree required; advanced degree (JD, MS, PhD) in a relevant scientific, regulatory, or legal field preferred
Minimum 5-7 years of progressive compliance or quality assurance experience within a cGMP-regulated biologics, cell therapy, or laboratory research environment
Demonstrated working knowledge of 21 CFR Parts 1271, 210, 211, and 600-680
Direct, hands-on experience with laboratory operations, testing protocols, and batch record review/release
Experience leading or supporting FDA inspections and audit responses
Professional compliance certification (e.g., CCEP, RAC, ASQ CQA) a plus
Strong understanding of Current Good Tissue Practice (CGTP) requirements for HCT/P laboratories
Excellent written and verbal communication skills, with the ability to train staff and report clearly to executive leadership
Strong organizational and documentation skills, with high attention to detail
Sound judgment and the ability to make independent compliance decisions under regulatory pressure
High ethical standards and a strong personal commitment to product safety and regulatory integrity
Comfortable working in and around a cGMP-compliant laboratory/cleanroom environment as needed Schedule
Full-time, Monday-Friday, on-site at our Yorba Linda, CA facility
Occasional availability outside standard hours may be required to support inspections, audits, or urgent compliance matters Employee Benefits
Competitive salary, commensurate with experience
Health insurance (medical, dental, and vision)
Paid time off (PTO) and paid holidays
401(k) retirement plan
Professional development support, including continuing education and certification renewal
Opportunity for growth within a rapidly expanding regenerative medicine research company
Collaborative, mission-driven team environment at the forefront of cell-based science Why Join Us Be part of a growing regenerative medicine research company at the forefront of cell-based science.

You'll work directly with executive leadership to build and safeguard a compliance program that supports research integrity, scientific excellence, and long-term regulatory success — with the autonomy to shape how compliance is run from the ground up. How to Apply Interested candidates should submit a resume and cover letter detailing relevant cGMP/cGTP compliance experience.

Pay:

$120,000.00 - $150,000.00 per year

Benefits:

Dental insurance Health insurance

Experience:

Chief Compliance Officer:

4 years (Required)

Work Location:

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