Quality Compliance Associate I/II

Capricor Therapeutics, Inc.; San Diego (CA); On-site; USD 70,000 - 82,000; Full time

Benefits offered by this job

Discretionary bonus

Equity incentives

Healthcare plan

401(k) with company match

Paid time off

Job summary

Capricor Therapeutics, Inc. in San Diego seeks an Audit/QA professional to lead internal audits of GxP processes, supplier audits, and CAPA programs. You will prepare detailed audit reports, track corrective actions, and support regulatory inspections.

Strong writing and cross-functional collaboration are essential. Requirements include a bachelor's degree in a scientific/technical field, 1–2 years of regulated-audit experience, and knowledge of FDA/ICH/GMP standards.

Qualifications

• Minimum one to two years of auditing experience in a regulated biopharma environment.
• Strong knowledge of regulatory requirements (FDA, ICH, EU GMP) and quality systems.
• Ability to produce clear audit reports with evidence and recommendations.

Responsibilities

• Plan, execute, and report on internal audits of GxP processes.
• Lead or support supplier/vendor audits and monitor performance.
• Prepare audit agendas, checklists, and sampling strategies.
• Document findings with classifications, evidence, and recommendations.
• Track CAPAs and drive timely closure.
• Support inspection readiness and liaise during regulatory inspections.
• Perform gap assessments against regulations and propose improvements.
• Collaborate across QA/QC, Manufacturing, Regulatory, and IT.
• Maintain audit schedules, metrics, and dashboards; report status to stakeholders.
• Contribute to policy/SOP development and continuous improvement.

Skills

Auditing experience

FDA 21 CFR Parts 210/211

ICH Q-series & GMP

Risk-based auditing

CAPA effectiveness verification

Root cause analysis

Documentation & reporting

Stakeholder management

Technical writing

Education

Bachelor's degree in a scientific or technical field

Certified Quality Auditor (CQA) - ASQ

Job description

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 isDeramiocel(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.

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).

$70,000 - $82,000 a year

Compensation and Benefits

The posted salary range represents Capricor's good-faith estimate of the salary range reasonably expected to be paid for this position at the time of hire. Final compensation will be determined based on job-related factors, including the candidate's relevant experience, education, skills, certifications, scope of role, location, and internal equity.

This position may also be eligible for a discretionary annual performance bonus and, depending on the level of the role, long-term equity incentive awards in accordance with company policy.

Capricor Therapeutics offers a comprehensive benefits package that includes employer-sponsored medical, dental, and vision coverage; company-paid basic life and AD&D insurance; a 401(k) plan with company match; paid time off and company holidays; and paid parental leave. Additional voluntary benefits and wellness programs may also be available.

Why Capricor?

Capricor Therapeutics is advancing cell and exosome-based therapies with a focus on serious diseases where patients and families need new treatment options. Our work is grounded in scientific rigor, collaboration, and a shared commitment to moving meaningful therapies forward. Joining Capricor means being part of a mission-driven team working at the intersection of innovation, execution, and patient impact.

Come Work With Us

At Capricor, you'll join a collaborative environment where employees are encouraged to contribute, grow, and help build the systems, science, and operations needed to support our next stage of growth. We value people who are thoughtful, accountable, hands-on, and motivated by work that can make a real difference.

Recruiting Fraud Notice

Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by someone using an official Capricor email address ending in @capricor.com. Capricor will never ask candidates to send money, deposit a check, purchase equipment, or provide payment for any reason as part of the recruiting or onboarding process.

Notice to Recruiting Agencies

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