Quality Assurance Director for Biologics Manufacturing
5 days ago
KE Select is recruiting a Quality Assurance Director to lead and manage all QA activities, ensuring compliance with regulatory requirements and excellence in quality management. This role involves collaborating closely with the Production and QC team to align quality systems with organisational goals.
Key Responsibilities- Strategic Leadership: Provide direction for the quality assurance function, aligning with organisational objectives and industry standards.
- Regulatory Compliance: Oversee compliance with FDA, EMA, and other regulatory requirements governing biologics manufacturing and quality systems.
- Quality Systems Management: Develop, implement, and maintain comprehensive quality systems, including document control, deviation management, and CAPA processes.
- Quality Assurance Operations: Manage batch release, product disposition, and oversight of manufacturing and testing activities.
- Risk Management: Implement risk-based approaches to quality management and develop strategies to mitigate risks associated with biologics manufacturing processes.
- Audits and Inspections: Coordinate regulatory inspections, customer audits, and internal audits, ensuring preparedness and timely response to audit findings.
- Continuous Improvement: Drive a culture of continuous improvement by identifying opportunities for process optimisation and quality enhancements.
This position requires a strong understanding of GMP and regulatory requirements, as well as experience in leading high-performing teams and developing quality systems. If you are a motivated and experienced quality professional looking to take on a strategic leadership role, please apply online or contact us for a confidential discussion.
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Brisbane, Queensland, Australia KE Select Full timeAbout KE SelectKE Select is a leading CDMO dedicated to the development, manufacturing, and distribution of nucleic acid products. Our commitment to ensuring the safety, efficacy, and compliance of products drives our success in meeting regulatory standards and exceeding customer expectations.About the RoleWe are seeking an experienced Senior Quality...
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