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Head of Quality Assurance

2 months ago

United Kingdom DNA Life Sciences Full time

Head Of Quality (Needs to be a Qualified Person QP)

DNA Life Sciences are partnered with a really exciting biotech who are currently looking for a Head Of Quality based just outside of Brighton.

They would be looking for this person to be based on sight at least 4 days on sight due to building quality function and the influence you would have on shaping this team.

Responsibilities

  • 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 all products, processes, and operations meet regulatory requirements and commitments.
  • Ensure accurate investigations of deviations/complaints to identify root causes and actions.
  • Ensure the PQS meets licensing requirements and current standards; support the development and implementation of the electronic QMS.
  • 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.
  • Lead support for audits/inspections and ensure the site is always inspection-ready.
  • Review and approve reports, procedures, policies, and non-conformance data.
  • Support the review/compilation of reports for PQRs, MAA, or BLA.
  • Lead and engage QA teams, guiding them through change.

Please not that this person does need to be a Qualified Person (QP).