Director of Quality Assurance (GCP)

| Greater NYC Area | Hybrid
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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.


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Technology we use

  • Engineering
  • Product
  • People Operations
    • JavascriptLanguages
    • PythonLanguages
    • ReactLibraries
    • ReduxLibraries
    • FlaskFrameworks
    • PostgreSQLDatabases
    • LookerAnalytics
    • FigmaDesign
    • MiroDesign
    • ConfluenceManagement
    • Google DriveManagement
    • Google DocsManagement
    • JIRAManagement
    • SlackCollaboration
    • ZoomCollaboration

Location

Our office is located in Manhattan, near the Empire State Building. The area is lively and has great food and transportation options!

An Insider's view of Formation Bio

What’s the vibe like in the office?

The space is very open which makes it easy to collaborate and engage with different teams across the organization. People are very welcoming, supportive, and friendly. There is always a variety of different food and drinks available in the kitchen, in addition to foods that co-workers bring in for everyone to taste!

Joseph Frappaolo

IT Support Technician

What projects are you most excited about?

The project that excites me most is our new hire onboarding program because of the impact it will have on our company. Though we have a robust onboarding program in place already, we have the opportunity to think creatively about how to make the experience even better for our new hires, from the moment they accept our offer.

Erin Siegel

Senior People Operations Manager

How has your career grown since starting at the company?

I started working at Formation Bio in July of 2018. I joined the company as a Clinical Research Coordinator and was allowed to grow and adapt into new roles as the company's business model shifted. I transitioned into working as a Clinical Trial Associate after a couple of years, and now have over a year of experience as a Clinical Project Manager!

Gurpreet Singh

Clinical Project Manager

How has your career grown since starting at the company?

Formation Bio has given me the opportunity to take ownership over big projects and work streams, allowing me to have an impact on key functional business areas.

Maya Dongier

Senior Accounting Manager

What are Formation Bio Perks + Benefits

Formation Bio Benefits Overview

Formation Bio 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!

Culture
Open door policy
Open office floor plan
Employee resource groups
Hybrid work model
Flexible work schedule
Diversity
Mandated unconscious bias training
Diversity employee resource groups
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Dental insurance
Vision insurance
Health insurance
Life insurance
Financial & Retirement
401(K)
Company equity
Pay transparency
Child Care & Parental Leave Benefits
Generous parental leave
Vacation & Time Off Benefits
Unlimited vacation policy
Paid holidays
Paid sick days
Office Perks
Company-sponsored outings
Yearly retreat and holiday party, regular team events and outings!
Free snacks and drinks
Company-sponsored happy hours
Fitness stipend
Home-office stipend for remote employees
Mother's room
Professional Development Benefits
Job training & conferences
Lunch and learns
Promote from within
Continuing education stipend
Virtual coaching services

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