Director of Quality Assurance (GCP)

| 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 Director of Quality Assurance, you will report directly to the Head of Quality Assurance and be responsible for developing, overseeing and managing the Quality Management System (QMS) in accordance with company policy and applicable regulations. Responsibilities will include:

  • Serving as the point of escalation on all GCP quality-related issues (ie GCP, GPC, CSV)
  • Leading the development of a TrialSpark Audit and Inspection playbook to ensure organizational readiness
  • Vendor quality oversight
  • Quality/compliant risk assessment
  • Issue management and corrective/preventative action management (CAPA)
  • Serving as audit/inspection lead for vendor/client audit and health authority inspections.

Experience

  • Bachelor or higher level degree in a scientific subject e.g. CS or Biology
  • Proven track record of 5-7 years+ experience working in the pharmaceutical QA industry.
  • In-depth expertise of ICH GCP
  • An entrepreneurial high growth learner who’s able to take initiative to learn new things.
  • Adaptable approach conducive to working in a fast paced, data-driven and evolving company.
  • Ability to rank, order and prioritize work.

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
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