Director of Quality Assurance (GCP)

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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