Associate Director - Quality Digital Data - Europe - Homebased
Multiple Locations: United Kingdom • Belgrade, Serbia • England, UK • France • Spain • Romania
Requisition Number: 6959
Position Title: Associate Director, Quality Digital Data
Who we are
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. 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. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
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. Ensuring that GxP eSystem activities are consistent and meet both external and internal requirements. Provide assurance with SOPs, Regulations, and guidelines for Worldwide processes.
What you will do
- 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
- Responsible for the GxP compliance of key eSystem vendors activities
- Manage QA liaison between designated vendors, Worldwide and Sponsors
- Vendor performance monitoring and ensure compliance to the Quality Agreement
- Perform CSV and IT related audits to ensure compliance with GMP, GDP, GVP and GCP and ensure the audits are reported and CAPA plans implemented to provide assurance of compliance with processes, regulations, guidelines, and agreements. Audits may be part of the internal audit or external vendor programs.
- 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
- Maintains knowledge of validation and IT requirements in relation to GxP activities.
- Act as a quality advocate, ensuring quality build an awareness in development of processes at Worldwide
What you will bring to the role
- Demonstrate organizational and critical decision-making skills
- Communicate professionally and concisely, both verbally and in writing
- Resourceful, conflict management, and negotiation skills
- Facilitate group or project initiatives and build team unity
- Work with a sense of urgency and recognize time sensitivity
- Strong understanding of validation and IT requirements for GxP principles and processes
- Collaborate effectively with cross-functional stakeholders
- 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)
- Excellent understanding of validation and IT requirements for GxP regulations and guidelines
- Knowledge of ICH Guidelines, FDA regulations, European Directives, MHRA Statutory Instruments, and AIFA CRO Decree
- Understanding of risk-based approaches to auditing
- Familiarity with the Drug Development Process
- Domestic and limited international travel required (approximately 35-40%)
At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.
Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers!
Employment Type: Regular
Community / Marketing Title: Associate Director - Quality Digital Data - Europe - Homebased
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.