Worldwide Clinical Trials

Director, Quality Vendor and Digital Data

Worldwide Clinical Trials

full-time

Posted on:

Location Type: Remote

Location: Remote • North Carolina • 🇺🇸 United States

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Job Level

Lead

Tech Stack

Google Cloud Platform

About the role

  • Responsible for a risk-based Quality Vendor Oversight Program to ensure quality of deliverables and compliance to GxP regulations.
  • Establish GCP Vendor quality agreements and GMP quality technical agreements with key external customers.
  • Establish QA to QA meetings for key vendors.
  • Defining and monitoring quality tolerance limits for Vendors working in collaboration with the Vendor Management Team.
  • Oversee the management of the QVD Audit Plan inclusive of vendors, depots, CSV, vendor, system, GMP and GDP audits/CAPAs.
  • Partner internally with key QA customers and operational internal stakeholders including to achieve Quality objectives.
  • Serve as a GCP/GxP subject matter expert for GMP, GDP, and GCP related services as applicable to Vendors and Systems.
  • Undertake GxP compliance oversight for new systems and operations championing a quality by design approach.
  • Identify and drive continuous improvement in GxP compliance for Worldwide Vendor and system processes activities.
  • Responsible for management and oversight of Vendor and system, quality issues, CAPA and Change control.
  • Support Worldwide inspections and Sponsor Audits as necessary.
  • Lead, mentor, and inspire a global team, fostering a collaborative and innovative environment.

Requirements

  • Bachelor’s degree or 4 year degree equivalent required; MS in a scientific or allied health field preferred.
  • Minimum of 12 years of relevant GxP experience.
  • Minimum of 4 years of management experience.
  • Experience of clinical, phase I and laboratory operations and systems.
  • Experience in Quality CSV OR: Knowledge of Clinical System Validation.
  • Advanced working knowledge of ICH Guidelines, FDA regulations, European Directives, UK Statutory Instruments.
  • Broad expertise related to understanding the GxP global requirements – regulations, laws and guidelines with the ability to identify key requirements and changes as they relate to Worldwide.
  • Understanding of 21 CFR Part 11 regulations and other international guidelines specifically addressing Computer Systems Electronic Record/Electronic Signature.
  • Domestic and international travel required (approximately 10-15%).
Benefits
  • Health insurance
  • 401(k) matching
  • Flexible work hours
  • Professional development opportunities
  • Remote work options

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
GxP complianceQuality Vendor OversightGCP Vendor quality agreementsGMP quality technical agreementsQuality tolerance limitsQVD Audit Plan managementCAPA managementChange controlClinical System ValidationICH Guidelines
Soft skills
leadershipmentoringcollaborationinnovationcommunication