Director of Quality Assurance

5 days ago


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

Job Summary

DNA Life Sciences is seeking a highly experienced and skilled Head of Quality Assurance to join our team. As a key member of our organization, you will be responsible for ensuring the highest standards of quality and compliance across all aspects of our business.

Key Responsibilities

  • Develop and Implement Quality Strategy: Define and drive the vision and strategy for the site QA function, ensuring alignment with company goals and objectives.
  • Quality Standards and Metrics: Set quality standards, targets, and measures, and oversee performance metrics for the QA function to ensure continuous improvement.
  • Regulatory Compliance: Ensure all products, processes, and operations meet regulatory requirements and commitments, maintaining a strong reputation for quality and compliance.
  • Investigation and Root Cause Analysis: Lead accurate investigations of deviations/complaints to identify root causes and actions, ensuring prompt resolution and continuous improvement.
  • Quality Management System: Ensure the PQS meets licensing requirements and current standards, supporting the development and implementation of the electronic QMS.
  • Leadership and Collaboration: Lead Quality Council and Change Management forums, and escalate issues as needed, promoting a culture of quality and compliance throughout the organization.
  • Quality Ownership and Efficiency: Promote ownership of quality and compliance, ensuring QA processes are lean and efficient, and lead support for audits/inspections to ensure the site is always inspection-ready.
  • Reporting and Review: Review and approve reports, procedures, policies, and non-conformance data, ensuring accuracy and completeness.
  • Regulatory Reporting: Support the review/compilation of reports for PQRs, MAA, or BLA, ensuring timely and accurate submission.
  • QA Team Leadership: Lead and engage QA teams, guiding them through change, and promoting a culture of quality and compliance.

Requirements

The ideal candidate will be a qualified person (QP) with a strong background in quality assurance and compliance, with experience in leading QA teams and developing quality strategies. They will possess excellent communication and leadership skills, with the ability to drive change and promote a culture of quality and compliance.



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