Job Description

Job Description

Job Description

Capricor Therapeutics, a publicly traded (NASDAQ: CAPR) biotechnology leader, is driven by a mission to develop groundbreaking biologics—focusing on cell and exosome-based therapies—to make a meaningful impact on patients’ lives, particularly for severe conditions like Duchenne muscular dystrophy with our lead therapy, deramiocel (CAP-1002). Our innovative work extends to our StealthX™ exosome platform, harnessing cutting-edge science to address unmet medical needs through precision-engineered solutions. At the heart of everything we do is a deep commitment to patient-centered innovation, fueled by strong academic partnerships and a passion for advancing healthcare.

As the Quality Business Analyst on Capricor’s Quality Systems team, you will play a critical role in driving compliance, operational excellence, and data integrity across our GMP and GxP environments. This position bridges business analytics with quality assurance, transforming raw data from manufacturing, clinical, and laboratory processes into actionable insights. You’ll design and monitor key quality metrics, support audits and regulatory readiness, and enable strategic decision-making through robust reporting and continuous improvement initiatives. Ideal candidates thrive in a fast-paced biotech setting, combining analytical rigor with a deep understanding of quality systems that safeguard patient safety and product reliability.

• Develop and track Quality KPIs aligned with GxP compliance, clinical trial readiness, and manufacturing standards to ensure product integrity and regulatory adherence.
• Analyze quality performance data from batch records, deviation logs, CAPA systems, and audit findings to identify systemic risks, process inefficiencies, and compliance gaps.
• Design and maintain dashboards and visualization tools for real-time monitoring of critical quality metrics such as deviation closure rates, audit observations, and batch release timelines.
• Partner with Quality Assurance, Quality Control, and Regulatory teams to gather requirements for process improvements, SOP updates, and system enhancements supporting FDA and EMA guidelines.
• Conduct root cause analyses for deviations, out-of-spec results, and data integrity issues; recommend corrective and preventive actions (CAPAs) grounded in data-driven insights.
• Author and maintain documentation including quality process flows, functional specifications for LIMS/QMS systems, and SOPs to support compliance and operational excellence.
• Support internal and external audits (FDA, EMA, ISO) by preparing data packages, ensuring documentation accuracy, and facilitating responses to observations.
• Lead continuous improvement initiatives leveraging Lean/Six Sigma methodologies to streamline quality workflows, reduce cycle times, and enhance compliance robustness.
• Deliver actionable insights and reports to Quality leadership and executive stakeholders to inform strategic decisions on risk mitigation, resource allocation, and regulatory readiness.
• Validate new system implementations and process changes (e.g., QMS upgrades, electronic batch record systems) to confirm alignment with 21 CFR Part 11 and other regulatory standards.
• Stay current on evolving regulatory requirements and industry best practices in quality analytics, data integrity, and compliance to proactively recommend enhancements.

• Bachelor’s Degree in a relevant field (e.g., Business Analytics, Data Science, Pharmaceutical Sciences, or related) and experience in a pharmaceutical, biotech, or FDA-regulated environment.
• Minimum of 5 years of experience in business analytics in a regulated environment.
• Lean Six Sigma certifications.
• Above-average/excellent abilities in Excel.
• Experience in Kaizen, workstream, and workflows.
• Demonstrated ability to run director-level meetings.
• In-depth knowledge of Quality Systems and pharmaceutical regulatory requirements, including 21 CFR Parts 11/210/211, ICH Q8, ICH Q9, and ICH Q10 guidelines.
• Strong analytical and problem-solving skills, with the ability to interpret complex datasets and derive meaningful insights.

• Experience across both small biotech startups and large pharmaceutical organizations, demonstrating adaptability to different compliance environments and operational scales.
• Proven project management skills, including the ability to lead cross-functional initiatives and deliver on timelines in a regulated setting.
• Hands-on exposure to quality or manufacturing operations, such as supporting GMP documentation, deviation investigations, or batch record reviews.
• Track record as both an independent contributor and a collaborative team member, thriving in matrixed environments with multiple stakeholders.
• Familiarity with advanced biotech processes—such as cell therapy, exosome-based therapeutics, or other novel modalities—highly advantageous for understanding Capricor’s platform.
• Comfort with quality systems and tools (e.g., QMS, LIMS, electronic batch records) and knowledge of regulatory frameworks like FDA, EMA, and ICH guidelines.

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.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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