Overview
Quality Business Analytics Specialist Jobs in San Diego, CA at Capricor Inc
Full Job Description
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 Quality Business Analytics Specialist will play a critical role in ensuring the accuracy, efficiency, and effectiveness of Quality Systems and operations by analyzing data, identifying process gaps, and implementing quality improvement initiatives. This role combines business analytics with a strong focus on quality assurance to drive continuous improvement and operational excellence.
Responsibilities:
Reporting KPIs data in alignment with the QMR requirements.
Analyze performance metrics, and system outputs to identify areas for improvement.
Develop and maintain data quality standards, KPIs, and dashboards to support performance monitoring.
Collaborate with cross-functional teams to gather and define quality requirements.
Conduct root cause analysis of process or data quality issues and recommend solutions.
Develop detailed documentation including quality requirements, process flows, and functional specifications.
Support quality audits, clinical study management, risk assessments, and compliance monitoring.
Facilitate continuous improvement initiatives.
Provide actionable insights and reports to stakeholders to support strategic decisions.
Test and validate new systems, process changes, or data models to ensure quality outcomes.
Requirements
Bachelor’s Degree and 5+ years’ experience in pharmaceutical or FDA environment
Preferred 2+ years’ experience business analytics and strategic planning
Minimum of 3 years of Quality Assurance or Quality Systems management experience in a GMP environment
Knowledge of Quality Systems and pharmaceutical regulatory requirements (21 CRF Part 11/210/211, ICH 8, ICH 9, and ICH 10)
Strong analytical and problem-solving
Excellent communication and documentation skills with experience in tools like Excel and Power BI
Proficient in PowerPoint to transfer and format large data sets in creating professional slides with clear visualizations for executive-level review
Ability to work independently and manage multiple work assignments in a fast-paced environment
Work Environment / Physical Demands
Must be able to sit or stand for extended periods, move around the facility, communicate effectively, and lift/carry up to 40 lbs.
Ability to gown and work in a classified area as required.
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!
Title: Quality Business Analytics Specialist
Company: Capricor Inc
Location: San Diego, CA
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