Capricor Therapeutics, Inc.
Quality Business Analytics Specialist
Capricor Therapeutics, Inc., San Diego, California, United States, 92189
Join to apply for the
Quality Business Analytics Specialist
role at
Capricor Therapeutics, Inc.
Base Pay Range $95,000.00/yr - $115,000.00/yr
About Capricor Therapeutics, Inc. 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.
Responsibilities
Create, manage, and report business KPIs to improve all areas of the business.
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 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.
Preferred Qualifications (NICE TO HAVES)
Experience in both small and large‑sized companies.
Project management experience.
Experience in quality/manufacturing roles.
Experience as both an individual contributor and team collaborator.
Familiarity with biotech‑specific processes, such as cell therapy or exosome technologies, is advantageous but not required.
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.
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.
#J-18808-Ljbffr
Quality Business Analytics Specialist
role at
Capricor Therapeutics, Inc.
Base Pay Range $95,000.00/yr - $115,000.00/yr
About Capricor Therapeutics, Inc. 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.
Responsibilities
Create, manage, and report business KPIs to improve all areas of the business.
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 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.
Preferred Qualifications (NICE TO HAVES)
Experience in both small and large‑sized companies.
Project management experience.
Experience in quality/manufacturing roles.
Experience as both an individual contributor and team collaborator.
Familiarity with biotech‑specific processes, such as cell therapy or exosome technologies, is advantageous but not required.
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.
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.
#J-18808-Ljbffr