Full Description

USA, Japan, India, Poland, Ireland & UK Time Zones Role Overview

A leading global Pharmaceutical organisation is seeking an experienced QA Specialist to support the organisation's Digital Transformation (DX) Enterprise Roadmap. The successful candidate will provide Quality Assurance oversight of enterprise-wide digital initiatives, ensuring innovative technologies, AI-enabled solutions, SaaS platforms, and GxP computerised systems are implemented and maintained in compliance with regulatory requirements and internal quality standards.

This role sits at the intersection of Quality Assurance, Digital Transformation, AI Governance, and GxP compliance. The position will focus on quality oversight, supplier quality management, documentation review, risk management, and the development of quality frameworks that enable digital innovation while maintaining compliance and inspection readiness.

Key Responsibilities Provide QA oversight of digital transformation initiatives and enterprise-wide programmes with GxP impact. Support the Quality Assurance strategy for Astellas' Digital Transformation (DX) Enterprise Roadmap. Provide QA review and approval of documentation associated with new and modified GxP systems, SaaS applications, and AI-enabled solutions.

Review and approve validation and lifecycle documentation, including

• Validation Plans and Reports
• User Requirements Specifications (URS)
• Risk Assessments
• Traceability Matrices
• Test Plans and UAT documentation
• Data Migration and Change Control documentation
• Ensure compliance with Data Integrity requirements, GxP regulations, 21 CFR Part 11, and Annex 11.
• Review and approve vendor-generated quality, validation, and compliance documentation.
• Support supplier quality activities, including vendor oversight and Quality Agreement review.
• Assess compliance risks associated with AI technologies, cloud platforms, and digital systems.
• Adapt and enhance existing quality processes, procedures, and quality management documentation to support AI and emerging technologies.
• Collaborate with business, IT, validation, data, and digital transformation teams to ensure appropriate quality governance across innovative technologies.
• Support audit and inspection readiness activities for digital and GxP systems.
• Provide guidance to stakeholders on quality expectations, regulatory requirements, risk assessments, and compliance strategies.

Requirements Degree in Science, Engineering, Computer Science, Quality, Information Systems, or a related discipline. 5+ years of Quality Assurance experience within a GxP-regulated pharmaceutical, biotechnology, or life sciences environment. Strong experience providing QA oversight of computerised systems, digital platforms, SaaS applications, or validation activities. Experience reviewing and approving validation and quality documentation. Experience supporting supplier quality activities and vendor oversight. Experience reviewing or supporting Quality Agreements. Strong understanding of GMP/GxP regulations and Data Integrity principles. Knowledge of 21 CFR Part 11 and Annex 11 requirements. Experience supporting large-scale digital or business transformation programmes. Excellent stakeholder management and communication skills.

Nice to Have Experience supporting AI-enabled technologies, machine learning platforms, or AI governance frameworks. Experience within digital transformation or enterprise innovation programmes. Experience supporting SaaS or cloud-hosted GxP applications. QA oversight experience across Computer System Validation (CSV) activities. Experience with systems such as Veeva, Salesforce, TrackWise, MasterControl, SAP, LIMS, or ELN. Exposure to Computer Software Assurance (CSA) methodologies. Experience within pharmaceutical manufacturing, biologics, API, or commercial operations.