Director, Quality Vendor and Digital Data
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Job Description
Director of Quality Vendor and Digital Data overseeing compliance and quality at Worldwide Clinical Trials. Leading a global team to ensure GxP compliance and drive continuous improvement.
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.
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
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