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Director of Quality Assurance
2 months ago
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.