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2 months ago
**About the Role**
DNA Life Sciences is seeking a highly skilled and experienced professional to lead our Quality Assurance function. As the Head of Quality Assurance, you will be responsible for defining and driving the vision and strategy for our site QA function.
Key Responsibilities
- Quality Vision and 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, ensuring accurate and timely reporting.
- Regulatory Compliance: Ensure all products, processes, and operations meet regulatory requirements and commitments, including adherence to Good Manufacturing Practices (GMP) and other relevant regulations.
- Investigation and Root Cause Analysis: Ensure accurate investigations of deviations/complaints to identify root causes and actions, and implement corrective and preventive actions as necessary.
- Quality Management System (QMS): Ensure the PQS meets licensing requirements and current standards, and support 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 Process Improvement: Promote ownership of quality and compliance, ensuring QA processes are lean and efficient, and lead support for audits/inspections and ensure the site is always inspection-ready.
- Reporting and Documentation: Review and approve reports, procedures, policies, and non-conformance data, and support the review/compilation of reports for PQRs, MAA, or BLA.
- Team Leadership: Lead and engage QA teams, guiding them through change, and ensure a high level of quality and compliance across all aspects of the organization.
Requirements
This role requires a Qualified Person (QP) with a strong background in quality assurance and regulatory compliance. The ideal candidate will have experience leading QA teams and implementing quality management systems.
