Associate Director

2 months ago


United Kingdom Worldwide Clinical Trials, LLC Full time

It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,000 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way. What Associate Director Quality Digital Data does at Worldwide
Responsible for quality operational oversight of GxP Quality activities with a focus on Computer System Validation (CSV), Electronic Records and Data and associated IT Quality activities including compliance for security/cyber security. Including managing Quality Issues, hosting audits and inspections at Worldwide, conducting/oversight of CSV audits of Worldwide eSystem vendors and QA oversight of contracts and quality agreements. Provide assurance with SOPs, Regulations, and guidelines for Worldwide processes.
Champion and adhere to Worldwide's Quality Management System (QMS)
Ensures Worldwide IT and computer systems supporting Worldwide pharmaceuticals research activities are conducted in compliance with GxP, EU Directives, International Conference on Harmonization (ICH) and Worldwide Policies and Procedures, as applicable
Manage QA liaison between designated vendors, Worldwide and Sponsors
Vendor performance monitoring and ensure compliance to the Quality Agreement
Provides QA consultancy to the Worldwide operations relating to compliance requirements for electronic systems and data.
Elevates serious and/or systemic issues with appropriate recommendations/solutions to Senior Management for immediate and long-term resolution in accordance with Worldwide procedures.
Participate in review of Quality issues relating security which may require reporting as Serious Breach.
Actively participates in quality related Audit & Inspection activities and meetings as necessary
Generates and monitors Key Quality Indicators (KQIs) and Quality Tolerance Limits (QTLs) in accordance with the QMS
Develops and maintains Quality agreements with vendors as required.
Prepare and review quality documents including Quality Agreement, SOPs, deviations, change control, complaints.
May participate in the development and delivery of training materials related to the QA, for CSV and IT related activities
Serves as a Subject Matter Expert on QA Quality Management Documents for eSystems and electronic data with vendors
Act as a quality advocate, ensuring quality build an awareness in development of processes at Worldwide
Communicate professionally and concisely, both verbally and in writing
Resourceful, conflict management, and negotiation skills
Facilitate group or project initiatives and build team unity
Fluency in English (speaking, reading, and writing)
Proficiency in Microsoft applications (Excel, Word, eQMS, PowerPoint)
Bachelor's degree or equivalent in a relevant field (e.g. Computer Science or other related science) and minimum 6 years of IT and CSV experience in a GCP, GLP, or GMP regulated environment
at least 7 years of experience in quality and regulatory compliance roles for GxP activities (including QA audits particularly CSV/Digital data audits)
Previous experience participating in regulatory inspections (FDA, MHRA, Health Canada, EMA)
Understanding of risk-based approaches to auditing
Domestic and limited international travel required (approximately 35-40%)
Why Worldwide
At Worldwide, we balance fun with the serious business of changing lives. Interested in hearing more about Worldwide or our roles? LI-Remote
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