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Director of Quality Assurance

2 months ago


Brighton, Brighton and Hove, United Kingdom DNA Life Sciences Full time

Job Overview

DNA Life Sciences is seeking a highly experienced and skilled Head of Quality Assurance to join their team. As a key member of the organization, this individual will be responsible for driving the quality function and ensuring that all products, processes, and operations meet regulatory requirements and commitments.

Key Responsibilities

  • Develop and Implement Quality Strategy
    • Define and drive the vision and strategy for the site QA function.
    • Set quality standards, targets, and measures, and oversee performance metrics for the QA function.
  • Ensure Regulatory Compliance
    • Ensure all products, processes, and operations meet regulatory requirements and commitments.
    • Ensure accurate investigations of deviations/complaints to identify root causes and actions.
  • Lead Quality Teams
    • Lead Quality Council and Change Management forums, and escalate issues as needed.
    • Promote ownership of quality and compliance, ensuring QA processes are lean and efficient.
  • Support Audits and Inspections
    • Lead support for audits/inspections and ensure the site is always inspection-ready.
    • Review and approve reports, procedures, policies, and non-conformance data.
  • Collaborate with Cross-Functional Teams
    • Support the review/compilation of reports for PQRs, MAA, or BLA.
    • Lead and engage QA teams, guiding them through change.

Requirements

  • Qualified Person (QP) certification is required.