Lead GCP Auditor

Auditing · REMOTE, Pennsylvania
Department Auditing
Employment Type Full-Time
Minimum Experience Experienced

Diligent is growing our team of in-house auditors to perform GCP Vendor Qualification Assessments and audits! Come join our mission to transform the vendor qualification process in clinical trials, and enjoy the benefits of being a full-time member of our remote team:

  • Benefits package, including medical, dental, vision, 401k
  • Paid time off
  • Steady work that comes to you
  • Flexible schedule and work-life balance
  • Remote auditing opportunities
  • Work alongside a supportive, passionate team dedicated to improving clinical trial execution

About Us

Diligent is an early-stage technology company that spun off from a successful and well-established business that was a pioneer in the clinical research industry. The organization has a mission-driven and values-driven culture that encourages entrepreneurialism, determination, and resourcefulness.

The Diligent Qualification Platform is a cloud-based technology and suite of services that enables Sponsors and CROs to rapidly identify, evaluate and select clinical service providers. Diligent addresses inefficiency and time delays in clinical trial execution and is the only company in the industry providing a solution to reduce redundancy around Vendor Qualification for clinical trials. Over 100 leading CROs, tech companies and service providers trust the Diligent platform to streamline their RFI (Request for Information) and VQA (Vendor Qualification Assessments) completion processes. 

We are currently seeking a Lead Auditor. The ideal candidate will be able to work collaboratively in a start-up environment and must be able to work in a flexible manner, handling a variety of different tasks to fulfill revenue needs while also working to meet the broader strategic goals of the business. 

Core Responsibilities

The Lead Auditor is responsible for providing technical process oversight and managing the successful delivery of Diligent’s Vendor Qualification Assessments (VQA’s) and Vendor Audits (VA’s) through the use of the Diligent Qualification Platform (DQP) processes. This role works closely with both the Sponsors and Providers to plan, execute and report on VQA’s and VA’s.  The day-to-day job responsibilities include, but are not limited to:

  • Provide process expertise and leadership to continuously improve the Diligent VQA and VA processes.
  • Maintain Knowledge of Global Regulatory Requirements for GCP Vendors, including but not limited to: FDA, EMA, MHRA, PMDA, CFDA, KFDA.
  • Prepare for Assigned VQA or VA Sessions and participate in Sponsor Scope Planning meetings to define the VQA or VA Scope.
  • Conduct assigned VQA or VA Sessions and author reports
  • Manage Vendor Corrective Action / Preventive Action (CAPA) Response Process and communication with Providers
  • Other duties as assigned by Head of Diligent Professional Services

Skills & Experience Required

  • Minimum of Bachelor’s Degree required, Advanced Degree preferred.
  • At least 15 Years experience in Quality Assurance, Quality Control, and/or Auditing in clinical research
  • Thorough knowledge of regulatory requirements for GCP vendors
  • Minimum of 10 years GCP Auditing Experience is required.
  • Strong written and verbal communication skills
  • Strong interpersonal skills
  • Strong analytical skills with high attention to detail
  • Strong capability utilizing Microsoft Word, Excel and Powerpoint

Thank You

Your application was submitted successfully.

  • Location
    REMOTE, Pennsylvania
  • Department
  • Employment Type
  • Minimum Experience