Quality Compliance Associate I/II

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most.

We are seeking an individual to join our Quality Compliance department. This role conducts internal and external audits to ensure our biopharma operations comply with applicable regulations, standards, and company procedures. The ideal candidate brings hands-on GMP/GxP auditing experience within the life sciences industry and partners cross-functionally to drive continuous improvement and a strong culture of compliance.

Key Responsibilities

• Plan, execute, and report on internal audits of GxP processes (e.g., GMP manufacturing, QC, validation, laboratories, supply chain).
• Lead or support supplier/vendor audits and monitor ongoing supplier performance.
• Prepare detailed audit agendas, checklists, and sampling strategies aligned with risk and compliance priorities.
• Document findings clearly; issue audit reports with classifications, evidence, and actionable recommendations.
• Track and verify effectiveness of CAPAs (Corrective and Preventive Actions) and drive timely closure.
• Support inspection readiness activities and host/liaise during regulatory inspections (e.g., FDA, EMA, MHRA).
• Perform gap assessments against current regulations and industry standards; propose reasonable improvements.
• Collaborate with QA/QC, Manufacturing, Regulatory, Supply Chain, and IT to strengthen quality systems.
• Maintain audit schedules, metrics, and dashboards; communicate status to stakeholders and management.
• Contribute to policy/SOP development, training, and continuous improvement initiatives.
  
  
  

Minimum Qualifications

• Bachelor's degree in a scientific or technical field (e.g., Chemistry, Biology, Engineering) or equivalent experience.
• 1-2 years of auditing experience within biopharma, biotech, medical devices, or related regulated industry.
• Working knowledge of FDA 21 CFR Parts 210/211, ICH Q-series, EU GMP, and GDP principles.
• Experience performing audits against quality system elements (Deviation, CAPA, Change Control, Training, Document Control).
• Strong technical writing skills and attention to detail; able to produce clear, evidence-based audit reports.
• Proficiency with risk-based auditing, root cause analysis, and CAPA effectiveness verification.
• Excellent communication and stakeholder management skills; comfortable engaging at all levels.
  
  
  

Preferred Qualifications

• Certified Quality Auditor (CQA) - ASQ, or equivalent certification.
• Experience auditing CMOs/CDMOs and complex supply chains.
• Background with data integrity, CSV, Annex 11, and Part 11 assessments.
• Exposure to biologics, cell & gene therapy, aseptic processing, or sterile manufacturing.
• Knowledge of ISO 9001/13485, 21 CFR 210/211, and pharmacovigilance quality systems (as applicable).
  
  
  

Why Capricor?

Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that’s transforming lives with every breakthrough.

Come Work With Us!

At Capricor, you’ll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies.

Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which is @capricor.com. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason.

Notice to Recruiting Agencies

Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Work Conditions:

• Hybrid role based in San Diego
• Travel up to 20% for supplier audits