Worldwide Clinical Trials · 21 hours ago
Director, Quality Vendor and Digital Data - US/Canada - Remote
United States
Full-time
Remote
Director/Executive
12+ years expWorldwide Clinical Trials is a global, midsize CRO dedicated to improving lives through innovative approaches. The Director of Quality Vendor and Digital Data will oversee a risk-based Quality Vendor Oversight Program, ensuring compliance with GxP regulations and leading a global team to foster a culture of quality and continuous improvement.
Health CarePharmaceutical
Responsibilities
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
Qualification
Required
Bachelor's degree or 4 year degree equivalent required
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
Demonstrated organizational leadership competencies
Ability to lead a team of individuals with a clear vision and defined purpose
Demonstrated ability for driving results and role modeling as a cross functional collaborator
Strategic thinker, hands on, highly organized, detail oriented
Demonstrated ability to effectively communicate, escalate, and influence the outcomes of decision-making process
Has an advanced understanding of clinical research principles and processes for clinical trials
Experience with identifying and implementing regulatory changes within life sciences organizations
Previous experience with leading / participating in Regulatory Authority Inspections e.g.: FDA BIMO inspections, MHRA GCP inspections, Health Canada GCP inspections, EMA GCP inspections, or other international Regulatory inspections
Domestic and international travel required (approximately 10-15%)
Preferred
MS in a scientific or allied health field preferred
Company
Worldwide Clinical Trials
Worldwide Clinical Trials is a global CRO that provides preclinical and Phase I-IV clinical development services to pharmaceutical industry.
1001-5000 employees
H1B Sponsorship
Worldwide Clinical Trials has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (5)
2022 (3)
2021 (2)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2023-08-07Acquired
Leadership Team
Rosemarie Corrigan
Executive Vice President, Global Quality
Robyn Greener
Associate Director, Project Management
Recent News
2025-12-18
EIN Presswire
2025-11-19
2025-09-22
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