Clinical GCP Quality Associate Director / Senior Manager

Join IMMIX Biopharma, Inc., a company committed to Intelligence, Integrity, and Initiative.

The Clinical GCP Quality Associate Director / Senior Manager will play a crucial role in providing Quality oversight for our clinical development programs to ensure compliance with ICH GCP and FDA regulatory requirements. You will actively collaborate with our clinical operations team and lead initiatives in vendor oversight, clinical site readiness, and inspection preparedness for clinical trials.

Key Responsibilities:

• Provide QA oversight for CROs, clinical sites, and service providers to ensure compliance with GCP.
• Support clinical vendor management initiatives, including qualification, monitoring, and performance management.
• Coordinate clinical site readiness for inspections and sponsor audits.
• Manage Trial Master File (TMF) readiness, conduct TMF audits, and oversee ongoing TMF periodic reviews.
• Perform on-site and remote clinical site audits to evaluate investigator site compliance with protocols, GCP, and applicable regulations.
• Review and provide QA input on clinical trial documentation (protocols, ICFs, monitoring plans).
• Support inspection readiness activities, including mock inspections, CAPA tracking, and documentation control.
• Assist Supplier Quality Manager with establishing and maintaining vendor quality agreements.
• Deliver GCP training to clinical operations and cross-functional teams.
• Support BIMO Inspections.

Qualifications:

• Bachelor's degree in Life Sciences, Nursing, or a related field; advanced degree preferred.
• 5-7 years of Clinical Quality Assurance (CQA) experience in pharma/biotech.
• In-depth knowledge of ICH E6 (R2/R3), FDA 21 CFR Part 312 guidelines.
• Proven experience in clinical site audits, TMF audits, and vendor oversight.
• Strong interpersonal, communication, and influencing skills.
• Willingness to travel (30-40%) for site/vendor audits.

At IMMIX Biopharma, Inc. (ImmixBio), we are at the forefront of addressing relapsed/refractory AL Amyloidosis, a serious condition where toxic light chains produced by the immune system can lead to organ failure. Our innovative lead candidate, NXC-201, is designed to train the immune system to eliminate these toxic substances effectively. We are conducting a U.S. multi-center study for NXC-201, which has received Regenerative Medicine Advanced Therapy (RMAT) designation from the US FDA and Orphan Drug Designation (ODD) from both the FDA and EMA.