• Provide quality oversight across GMP-regulated activities, supporting manufacturing and operational teams to ensure adherence to regulatory expectations (FDA, EMA, ICH). • Lead the review and approval of controlled documents, ensuring accuracy and compliance throughout the product lifecycle. • Actively support Change Management processes by assessing proposed changes, ensuring risk mitigation, and tracking implementation status. • Deliver tailored training sessions for cross-functional project teams to build awareness and operational capability in Change Control and Quality System processes. • Collaborate with internal stakeholders to maintain audit readiness, support inspections, and drive continuous improvement initiatives. • Contribute to cross-site harmonisation of quality practices and documentation systems, strengthening the QMS framework across business units.

• Perform batch documentation review to support product disposition activities of drug product and finished product that meet commercial customer requirements while ensuring compliance with testing standards, SOPs, validation guidelines and regulatory filings. • Author, compile and maintain documentation needed for disposition of the product from Contract Manufacturing Organizations (CMOs) • Review disposition documentation, escalating potential issues • Ensure batch documentation relative to CMO materials and products is maintained and archived • Evaluate external quality complaint investigations provided by CMOs • Input required deviation, complaint, change control, and product disposition information into applicable enterprise systems • Prepare and review of Quality Agreements with external manufacturers and external laboratories • Assist in preparation of Annual Product reviews as required for end to end product monitoring • Support / backup role of VPT QA representative to ensure coordination of quality events, change control and market complaints programs in respect of Third Party Manufacturer and Alliance Partnership relationships • Provide support to specified quality and technical projects as they arise

• Managed validation and compliance activities for laboratory equipment, ensuring adherence to ISO 13485, CE-IVD, and FDA regulatory standards. • Oversaw documentation control for equipment calibration, validation (IQ/OQ/PQ), and maintenance within the quality system framework. • Maintained and updated QMS records for laboratory operations, supporting audit readiness and traceability. • Provided quality oversight and GxP compliance guidance to operational departments, fostering a culture of accountability and continuous improvement. • Supported the planning and execution of QC and QAOps activities, including batch release coordination via Dynamics and Jira platforms. • Guided Non-Conformance owners through investigation and resolution processes, contributing to timely and effective CAPA implementation. • Authored and reviewed quality documents, including QC certificates and QA-related reporting. • Acted as internal auditor, contributing to successful inspections and quality system audits.