Find & Apply For Compliance Officer / Analyst Jobs in Yorba Linda, California

Chief Compliance Officer Proctor Life Sciences Yorba Linda, CA Job Details Full-time $120,000 - $150,000 a year 1 hour ago Benefits Paid holidays Health insurance Dental insurance 401(k) Paid time off Vision insurance Qualifications Teamwork Quality assurance in testing Bachelor's degree Attention to detail Biomedical regulatory compliance Quality audits Experience in a research and development laboratory environment GMP for research safety and compliance FDA regulations Full Job Description Chief Compliance Officer Regenerative Medicine Research Laboratory Proctor Life Sciences | Yorba Linda, CA | Full-Time About Us Proctor Life Sciences is a cGMP/cGTP-regulated biologics research laboratory specializing in cell processing, MSC and NK cell programs, and HCT/P research and development. Our team advances regenerative medicine research through rigorous scientific standards, disciplined quality systems, and full regulatory integrity. As we continue to grow, we're looking for an experienced Chief Compliance Officer to lead our compliance function and ensure our laboratory operations remain in continuous FDA compliance. Position Summary The Chief Compliance Officer (CCO) is a senior leadership role responsible for building, maintaining, and continuously strengthening our compliance program in accordance with FDA regulations governing human cellular and tissue-based products (HCT/Ps) and cGMP-regulated laboratory operations. This is a full-time, on-site position with direct authority and accountability for keeping the facility inspection-ready at all times, reporting to the Chief Executive Officer. Key Responsibilities

• 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:

In person