Associate Director / Sr.Manager - Clinical GCP Quality

IMMIX Biopharma, Inc.

Our 3 Core Values

• Intelligence
• Integrity
• Initiative

What You'll Do

The Clinical GCP Quality lead will provide Quality oversight of clinical development programs to ensure compliance with ICH GCP and FDA regulatory requirements. The role will actively support clinical operations team, 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.
• Actively support clinical vendor management initiatives, including qualification, monitoring, and performance management.
• Coordinate clinical site readiness for inspections and sponsor audits.
• Manage 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.
• Support Supplier Quality Manager with establishment and maintenance of vendor quality agreements.
• Provide GCP training to clinical operations and cross-functional teams.
• Ability to support BIMO Inspections.

Qualifications

• Bachelor's degree in Life Sciences, Nursing, or 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.
• Demonstrated 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.

About IMMIX Biopharma, Inc.

Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a global leader in relapsed/refractory AL Amyloidosis. AL Amyloidosis is a devastating disease where the immune system, that's supposed to protect, instead produces toxic light chains, clogging up the heart, kidney and liver, causing organ failure and death. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 with a "digital filter" that is designed to filter out non-specific activation. NXC-201 teaches the immune system to recognize and eliminate the source of the toxic light chains. NXC-201 is being evaluated in the U.S. multi-center study for relapsed/refractory AL Amyloidosis NEXICART-2 (NCT06097832), with a registrational design. NXC-201 has been awarded Regenerative Medicine Advanced Therapy (RMAT) by the US FDA and Orphan Drug Designation (ODD) by FDA and in the EU by the EMA.