CAPA Manager at TrialSpark
TrialSpark is a technology company that brings new medical treatments to patients faster by reimagining the clinical trial process. Today, a clinical trial can cost more than $100M and take 10 years to complete, bottlenecking the development of new treatments for patients.
Our company is using software and technology to streamline all aspects of a clinical trial. By reducing the time and cost it takes to run a clinical trial, we empower more treatments to be ultimately brought to patients.
TrialSpark’s business lines:
In short, TrialSpark works with our Biotech and Pharma partners in 3 ways: 1) we provide standalone digital advertising-based patient recruitment services, 2) we operate trial sites in support of phase II-IV clinical trials, and 3) we run end-to-end Phase II studies as an alternative to a Contract Research Organization (CRO).
As our CAPA Manager you will ensure processes and systems are defined and implemented for central notification and tracking to oversee CAPA (Corrective and preventive action) management process for audits, inspections, deviations (non-compliances), and assessments in the clinical development and patient recruitment areas of our business.
Other responsibilities include:
- Collaborate across all cross-functional teams on implementation of CAPA activities and ensure that CAPAs are appropriately developed, and investigated to ensure that non-conformance would not be repeated; that CAPAs are assigned appropriate root cause and effectiveness actions are duly implemented.
- Ensure rigorous assessment of CAPA activities and documentation to assure compliance with applicable regulations and adequate compliance by partnering as per GCP, ICH regulations, guidelines and industry best practice
- Develop a systematic approach for managing process deviations and assessing its impact.
- Provide and ensure weekly, monthly CAPA updates to cross functional team across GxP to ensure that the organization is compliant with CAPA related deliverable and outputs
- Present CAPA status/effectiveness updates to Senior Leadership as part of regular Quality Review Meetings
- Liaise with business functions as well as Quality Assurance colleagues to ensure vendor related CAPAs are remediated as needed
- B.S degree in scientific, health care, or related discipline required
- At least 4+ years work experience in Quality Assurance or related field experience; Less experience may be appropriate with advanced degree.
- Strong people leadership skills and ability to influence others without direct authority
- Should be creative and show initiative, customer focused, results driven and able to work effectively in a dynamic and changing environment
- Experience with Root Cause Analysis methodologies.
- Excellent organizational and project management skills; prior experience managing large cross functional quality related projects.
You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.