Start Date
Immediate
Expiry Date
15 Jan, 27
Salary
551243.0
Posted On
19 Oct, 26
Experience
10 year(s) or above
Remote Job
Yes
Telecommute
Yes
Sponsor Visa
Yes
Skills
Industry
Financial Services & Insurance
• Deputize for the Director, Quality Assurance providing continuity of quality decision-making, risk escalation, and cross-functional leadership across manufacturing, supply chain, distribution, and R&D interfaces.
• Act as quality advisor and subject matter expert across the Quality Unit and wider organization, providing guidance on complex quality matters.
• Contribute to the development and execution of the Manufacturing Quality operating plan, including priorities and capability development, in alignment with enterprise Quality strategy.
• Provide quality oversight for CMC and GMP operations across the medicinal product lifecycle, including outsourced QP services, ensuring phase-appropriate compliance with applicable regulations, guidelines, standards, and internal quality processes.
• Support quality governance for Product Specification File (PSF) management and clinical supplies for investigational medicinal products (IMPs).
• Support quality oversight of commercial supply operations, including artwork management.
• Act as Quality lead, or support as required, for critical product quality events, ensuring effective decision-making, communication, and timely execution of containment and remediation actions.
• Support quality oversight of human tissue management operations, ensuring compliance with applicable international standards and ethical requirements.
• Contribute to Immunocore's regulatory inspection readiness program, ensuring quality systems, documentation, and processes are inspection-ready at all times.
• Monitor and analyze QMS KPIs and metrics, identify trends, emerging risks, and systemic opportunities for improvement, and report or escalate findings appropriately.
• Lead or contribute to root cause analysis and CAPA management for quality events, driving timely and effective resolution.
• Identify and recommend best practices or new solutions to improve processes, and/or compliance outcomes across the organization.
• Contribute to regulatory submissions, filings, and responses to regulatory information requests (RFIs), ensuring quality-relevant content is accurate and consistent.
• Partner cross-functionally to ensure effective quality oversight and alignment on shared objectives.
• Proactively engage key stakeholders across the business on complex and unique quality matters.
• Represent the Quality Unit at internal and external meetings, including cross-functional forums, as required.
• Contribute to quality management review processes, providing data-driven input on performance, risks, and improvement opportunities.
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