Capricor Therapeutics, Inc.
Business Analyst - Quality Assurance Optimization
Capricor Therapeutics, Inc., San Diego, California, United States, 92189
About Capricor Therapeutics
Capricor Therapeutics (NASDAQ: CAPR) 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 innovative platforms, including our lead product, deramiocel (CAP-1002), and our proprietary StealthX™ platform, to engineer cutting-edge treatments. Our team is committed to harnessing advanced science and 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
The Business Analyst - Quality Assurance Optimization Specialist will be instrumental in enhancing the accuracy, efficiency, and overall performance of our Quality Systems and operations. By leveraging data analytics to identify process inefficiencies, close gaps, and drive quality improvements, this role bridges business intelligence with quality assurance expertise. You'll support operational excellence in a dynamic GMP environment, ensuring compliance while enabling strategic decision-making through insightful reporting and continuous improvement initiatives. This position is ideal for a hands-on analyst who thrives in a mid-sized biotech setting and can balance analytical rigor with deep QA/QS knowledge.
Responsibilities: Report KPI data in alignment with Quality Management Review (QMR) requirements, ensuring timely and accurate submissions. Analyze performance metrics, system outputs, and operational data to identify trends, bottlenecks, and areas for improvement. Develop and maintain data quality standards, KPIs, interactive dashboards, and visualization tools to enable real-time performance monitoring and forecasting. Collaborate with cross-functional teams (including Quality, Operations, and R&D) to gather requirements, define quality processes, and align on improvement strategies. Conduct thorough root cause analyses for process deviations, data quality issues, or compliance risks, and propose actionable, data-driven solutions. Create detailed documentation, such as quality requirements, process flows, functional specifications, and standard operating procedures (SOPs). Support internal and external quality audits, clinical study management, risk assessments, deviation investigations, and ongoing compliance monitoring. Lead or facilitate continuous improvement initiatives, such as Lean/Six Sigma projects, to optimize workflows and enhance efficiency. Deliver actionable insights, reports, and presentations to stakeholders, including executive leadership, to inform strategic decisions and business planning. Test and validate new systems implementations, process changes, or data models to confirm they meet quality standards and deliver expected outcomes. Stay abreast of industry trends in quality analytics and regulatory updates to proactively recommend enhancements. Requirements:
Bachelor's Degree in a relevant field (e.g., Business Analytics, Data Science, Pharmaceutical Sciences, or related) and 5+ years of experience in a pharmaceutical, biotech, or FDA-regulated environment. Preferred: 2+ years of experience in business analytics, strategic planning, or data-driven decision support roles. Minimum of 3 years of hands-on Quality Assurance (QA) or Quality Systems (QS) management experience in a GMP-compliant setting. 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. Excellent communication and documentation skills, including proficiency in tools like Microsoft Excel, Power BI, and other analytics platforms for data manipulation and visualization. Advanced proficiency in PowerPoint for transforming large datasets into professional, executive-level slides with clear charts, graphs, and narratives. Ability to work independently, manage multiple priorities in a fast-paced environment, and adapt to evolving project needs. Experience with root cause analysis tools (e.g., Fishbone diagrams, 5 Whys) and quality management software is a plus. Familiarity with biotech-specific processes, such as cell therapy or exosome technologies, is advantageous but not required. Work Environment / Physical Demands:
Must be able to sit or stand for extended periods, move around the facility, communicate effectively (both verbally and in writing), and lift/carry up to 40 lbs. Ability to gown and work in classified cleanroom areas as required for GMP compliance. This is an on-site role with occasional flexibility for hybrid arrangements based on business needs.
Compensation (USD): $100,000 - $115,000 This role offers a competitive salary based on experience and qualifications. Additional benefits include health/dental/vision insurance, paid time off, parental leave, 401k retirement plan, company stock options, and bonus eligibility.
Location Policy This position is based at our headquarters in San Diego, California.
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 and making a real impact on patients' lives, we'd love to hear from you!
About the Role
The Business Analyst - Quality Assurance Optimization Specialist will be instrumental in enhancing the accuracy, efficiency, and overall performance of our Quality Systems and operations. By leveraging data analytics to identify process inefficiencies, close gaps, and drive quality improvements, this role bridges business intelligence with quality assurance expertise. You'll support operational excellence in a dynamic GMP environment, ensuring compliance while enabling strategic decision-making through insightful reporting and continuous improvement initiatives. This position is ideal for a hands-on analyst who thrives in a mid-sized biotech setting and can balance analytical rigor with deep QA/QS knowledge.
Responsibilities: Report KPI data in alignment with Quality Management Review (QMR) requirements, ensuring timely and accurate submissions. Analyze performance metrics, system outputs, and operational data to identify trends, bottlenecks, and areas for improvement. Develop and maintain data quality standards, KPIs, interactive dashboards, and visualization tools to enable real-time performance monitoring and forecasting. Collaborate with cross-functional teams (including Quality, Operations, and R&D) to gather requirements, define quality processes, and align on improvement strategies. Conduct thorough root cause analyses for process deviations, data quality issues, or compliance risks, and propose actionable, data-driven solutions. Create detailed documentation, such as quality requirements, process flows, functional specifications, and standard operating procedures (SOPs). Support internal and external quality audits, clinical study management, risk assessments, deviation investigations, and ongoing compliance monitoring. Lead or facilitate continuous improvement initiatives, such as Lean/Six Sigma projects, to optimize workflows and enhance efficiency. Deliver actionable insights, reports, and presentations to stakeholders, including executive leadership, to inform strategic decisions and business planning. Test and validate new systems implementations, process changes, or data models to confirm they meet quality standards and deliver expected outcomes. Stay abreast of industry trends in quality analytics and regulatory updates to proactively recommend enhancements. Requirements:
Bachelor's Degree in a relevant field (e.g., Business Analytics, Data Science, Pharmaceutical Sciences, or related) and 5+ years of experience in a pharmaceutical, biotech, or FDA-regulated environment. Preferred: 2+ years of experience in business analytics, strategic planning, or data-driven decision support roles. Minimum of 3 years of hands-on Quality Assurance (QA) or Quality Systems (QS) management experience in a GMP-compliant setting. 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. Excellent communication and documentation skills, including proficiency in tools like Microsoft Excel, Power BI, and other analytics platforms for data manipulation and visualization. Advanced proficiency in PowerPoint for transforming large datasets into professional, executive-level slides with clear charts, graphs, and narratives. Ability to work independently, manage multiple priorities in a fast-paced environment, and adapt to evolving project needs. Experience with root cause analysis tools (e.g., Fishbone diagrams, 5 Whys) and quality management software is a plus. Familiarity with biotech-specific processes, such as cell therapy or exosome technologies, is advantageous but not required. Work Environment / Physical Demands:
Must be able to sit or stand for extended periods, move around the facility, communicate effectively (both verbally and in writing), and lift/carry up to 40 lbs. Ability to gown and work in classified cleanroom areas as required for GMP compliance. This is an on-site role with occasional flexibility for hybrid arrangements based on business needs.
Compensation (USD): $100,000 - $115,000 This role offers a competitive salary based on experience and qualifications. Additional benefits include health/dental/vision insurance, paid time off, parental leave, 401k retirement plan, company stock options, and bonus eligibility.
Location Policy This position is based at our headquarters in San Diego, California.
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 and making a real impact on patients' lives, we'd love to hear from you!