CAPA Manager

| Greater NYC Area

Background

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).

Job Description

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

Relevant Experience

  • 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.

Read Full Job Description

Technology we use

  • Engineering
    • JavascriptLanguages
    • PythonLanguages
    • ReactLibraries
    • ReduxLibraries
    • FlaskFrameworks
    • PostgreSQLDatabases

Location

Our office is located in the Flatiron District of NYC, near Madison Square Park. The area is lively and has great food and transportation options!

An Insider's view of TrialSpark

What are some social events your company does?

We believe in healthy living! We organize regular team exercise classes as a company!

Frank Wu

Product Manager

How do you empower your team to be more creative?

We believe in presenting problems, not solutions, to the team. Our job is to align the team on company goals and issues, and allow the team to work creatively to solve them. We believe team autonomy fosters creativity and a healthier culture.

Linhao Zhang

CTO

What are TrialSpark Perks + Benefits

TrialSpark Benefits Overview

Trialspark is nothing without its employees, so they are well taken care of! We offer comprehensive benefits that span from insurance to 401ks, with added perks like a pet-friendly office. Come meet our office dog, Rosie!

Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Retirement & Stock Options Benefits
401(K)
Company Equity
Child Care & Parental Leave Benefits
Generous Parental Leave
Flexible Work Schedule
Vacation & Time Off Benefits
Unlimited Vacation Policy
Paid Holidays
Paid Sick Days
Perks & Discounts
Casual Dress
Commuter Benefits
We have a monthly transportation subsidy!
Company Outings
Yearly retreat and holiday party, regular team events and outings!
Free Daily Meals
We offer free lunch every day except Wednesday (when we encourage employees to leave the office and explore the area!)
Game Room
Super Smash Club every Friday!
Stocked Kitchen
Happy Hours
Pet Friendly
Come meet our office dog, Rosie!
Relocation Assistance
Fitness Subsidies
Professional Development Benefits
Job Training & Conferences
More Jobs at TrialSpark30 open jobs
All Jobs
Finance
Data + Analytics
Dev + Engineer
HR
Legal
Marketing
Operations
Product
Project Mgmt
Sales
Operations
new
New York
Operations
new
New York
Product
new
New York
Data + Analytics
new
New York
Operations
new
New York
Sales
new
New York
Operations
new
New York
Finance
new
New York
Project Mgmt
new
New York
Developer
new
New York
Marketing
new
New York
Operations
new
New York
Data + Analytics
new
New York
HR
new
New York
Marketing
new
New York
Marketing
new
New York
Marketing
new
New York
Marketing
new
New York
Product
new
New York
Developer
new
New York
Operations
new
New York
Developer
new
New York
HR
new
New York
Data + Analytics
new
New York
Operations
new
New York
Operations
new
New York
Sales
new
New York