Quality Assurance Supervisor, Clinical

About Capricor Therapeutics

Capricor Therapeutics is a biotechnology company dedicated to developing transformative therapies for rare diseases, with a primary focus on Duchenne muscular dystrophy (DMD). We are pioneers in cell therapy and exosome-based technology, leveraging our proprietary StealthX™ platform to engineer innovative treatments. Our team is committed to harnessing cutting-edge science and advanced technologies to meet the unmet needs of patients living with DMD and other challenging medical conditions. Join us on our journey as we push the boundaries of medical science and pave the way for a healthier future.

About the Role

We are seeking a meticulous and self-motivated Quality Assurance Supervisor, Clinical to join our Quality Assurance team. Reporting to the Director of Quality Assurance, you will play an essential role in supporting clinical and commercial product launch and production. This position requires a keen eye for detail, a passion for process improvement, and a commitment to enhancing patient lives through rigorous quality oversight. You will collaborate with cross-functional teams to ensure compliance with global regulatory standards and drive Capricor’s Culture of Quality program.

Responsibilities:

 • Partner with Quality and Clinical leaders to implement Capricor’s Culture of Quality program.
 • Oversee the development, review, and approval of key clinical quality documents, including SOPs and audit reports.
 • Maintain and update the clinical quality document management system to ensure proper documentation control and regulatory compliance.
 • Collaborate with counterparts to develop, implement, and maintain Quality Management Systems (QMS) compliant with FDA, EMA, and other global regulatory requirements for cell therapy products.
 • Support quality processes, risk assessments, audits, and regulatory/submission activities.
 • Perform additional duties as assigned.

Clinical Quality Oversight:

• Ensure clinical trial activities comply with regulatory requirements, including FDA 21 CFR Parts 11, 50, 54, 312, ICH E6 (GCP), and applicable local, national, and international regulations.
• Approve investigations of SOP deviations, conducting root cause analysis, impact assessments, and guiding cross-functional teams on corrective actions.
• Oversee maintenance of the electronic Trial Master File (eTMF).
• Lead the Clinical Vendor Management Program.

Investigational Product (IP) Accountability:

• Monitor IP accountability processes, including documentation of receipt, inventory, and return records.
• Conduct audits of clinical sites and vendors to verify IP tracking logs and chain of custody align with GCP and regulatory standards.
• Provide guidance on IP shipment or accountability deviations and recommend corrective and preventive actions (CAPAs).

Audit and Inspection Readiness:

• Ensure readiness for regulatory inspections (e.g., BIMO) and act as the clinical quality assurance point of contact.
• Support internal and external GCP audits, develop audit reports, and recommend CAPAs.
• Ensure clinical sites and vendors maintain audit readiness and resolve findings effectively.

Regulatory Compliance:

• Monitor clinical trial activities for compliance with regulatory requirements, SOPs, and quality agreements.
• Assist with regulatory inspections, including preparation, support, and responses to findings.

Risk Management and Continuous Improvement:

• Assess and mitigate risks related to clinical quality and compliance with clinical teams.
• Identify and drive process improvement initiatives across clinical operations.

Training and Development:

• Develop and deliver GCP and clinical quality training for staff and stakeholders in collaboration with Clinical Operations.
• Mentor and supervise junior quality assurance staff, fostering growth and aligning team performance with organizational goals.

Requirements:

 • Minimum of 5-7 years of experience in clinical quality assurance, clinical research, or a related field in the pharmaceutical, biotechnology, or CRO industry.
 • At least 2 years of supervisory or leadership experience.
 • Proven experience conducting and managing GCP audits with expertise in risk-based auditing strategies.
 • Comprehensive knowledge of GCP, ICH guidelines, FDA regulations, and international clinical trial standards (e.g., EU Clinical Trials Regulation, EudraLex Volume 10).
 • Expertise in investigational product (IP) management, including chain of custody, storage, handling, and documentation.
 • Familiarity with regulatory guidelines (e.g., GDPR, HIPAA) related to clinical research data privacy and security.
 • Strong analytical, problem-solving, leadership, communication, and interpersonal skills with the ability to collaborate cross-functionally.
 • Excellent attention to detail, organizational skills, and record-keeping abilities.
 • Proficient in MS Word, Excel, Visio, Adobe Suite, and database systems.
 • Results-oriented with strong initiative, independence, and follow-through in a fast-paced, dynamic environment.
 • Comfortable managing multiple priorities and rapidly changing demands.

Compensation (USD): $90,000 - $120,000

• This role offers a competitive salary based on experience and qualifications. Additional benefits include health insurance, retirement plans, and opportunities for professional development. (Note: Salary range is estimated based on typical roles at this level; adjust as needed.) 

Location Policy:

This position is based at our headquarters in San Diego, California, with some flexibility for remote work depending on organizational policies.

Work Environment / Physical Demands:

 • Must be able to sit and stand for extended periods.
 • Must be able to lift/carry reports and materials up to 40 pounds, move about the office, communicate efficiently and effectively on the telephone or in person, and complete required paperwork.
 • This role may require periodic travel (up to 25%) to clinical sites, vendors, and other business locations for audits and inspections.

Come Work With Us!

Capricor Therapeutics is headquartered in San Diego, California. We offer competitive compensation and benefits, generous vacation and parental leave, flexible working hours, and a collaborative work environment. If you are excited about joining a team that’s transforming the biotech industry, we’d love to hear from you! At Capricor, you’ll be part of a forward-thinking team committed to improving lives through groundbreaking therapies. If you’re passionate about clinical quality assurance and supporting innovative biotech operations, we invite you to apply and help shape our future.

Salary : $90,000 - $120,000