Quality Assurance Leadership Role in GMP Manufacturing

1 day ago


San Diego, California, United States Kumquat Biosciences Inc Full time
About Kumquat Biosciences

Kumquat Biosciences Inc is a pioneering biotechnology company dedicated to revolutionizing cancer treatments through innovative drug discovery and development.

Job DescriptionExecutive Director, Quality Assurance

Estimated Salary: $180,000 - $220,000 per year

This leadership role plays a pivotal part in establishing and implementing quality management systems (QMS) that ensure compliance with global regulatory standards. As the Executive Director of Quality Assurance, you will oversee all aspects of quality assurance in cGMP manufacturing, including vendor qualification, auditing, and training programs.

Main Responsibilities:
  • Leadership and Management:
  • Build and lead a high-performing Quality Assurance team, fostering a culture of continuous improvement and accountability.
  • Develop and implement strategic quality plans aligned with company goals and regulatory requirements.
  • Collaborate with cross-functional teams to ensure quality standards are met throughout the product lifecycle.
  • Quality Systems and Oversight:
  • Oversee the development, implementation, and maintenance of QMS in compliance with GMP regulations.
  • Establish quality metrics, key performance indicators, and dashboards to monitor QMS performance.
  • Ensure all cGMP manufacturing processes, procedures, and documentation meet global regulatory standards.
  • Conduct regular audits and inspections of GxP vendors.
  • Review and approve manufacturing documents, such as method validation reports, master and executed batch records, API and DP release, CTM labeling, packaging, and distribution.
  • Risk Management:
  • Identify and mitigate quality risks through proactive measures and corrective actions.
  • Lead investigations into quality issues, deviations, and non-conformances, ensuring timely resolution and documentation.


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