Director to Executive Director, Quality Assurance
3 weeks ago
Kumquat Biosciences is committed to the discovery and development of innovative drugs to transform cancer treatments. Kumquat brings together an accomplished management team and distinguished scientific founder to translate innovative research to novel therapeutics. Our team has a proven track record of drug discovery and development, having played pivotal roles in the discovery of multiple clinical-stage compounds as well as approved drugs for the treatment of cancer and immune-mediated inflammatory diseases.
This position will play a leadership role in establishing and implementing the quality management system (QMS) and promoting quality culture to ensure compliance with relevant global GxP regulations (FDA, EU, and other countries) and inspection readiness. The position is accountable for quality oversight of all GxP activities internally and externally at CDMO/CROs, vendor qualification and auditing program, and quality agreements. He/She will collaborate with internal and external teams in addressing quality compliance events and proactively identify and mitigate issues. The position will be primarily responsible for all aspects of quality assurance in cGMP manufacturing of drug substance and drug product, CTM release, labeling and distribution, review and approval of cGMP manufacturing documents, and continuous improvement. The ideal candidate shall have extensive experience in quality assurance for cGMP manufacturing within the biotech and pharmaceutical sectors. Previous experience in hosting successful inspections by regulatory authorities (FDA, EMA etc.) is a plus.
Essential Responsibilities
Leadership and Management:
- Build and lead the Quality Assurance team, fostering a culture of continuous improvement and accountability.
- Develop and implement strategic quality plans in alignment with company goals and regulatory requirements.
- Collaborate with cross-functional teams to ensure quality standards are met throughout the product lifecycle.
- Oversee the development, implementation, and maintenance of quality management systems (QMS) in compliance with GMP regulations.
- Establish quality metrics, key performance indicators, and dashboards to monitor the QMS performance.
- Ensure all cGMP manufacturing processes, procedures, and documentation meet global regulatory standards (FDA, EMA, etc.).
- 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.
- Develop quality documents, SOPs, work instructions, etc.
- Lead the GxP Training Program and perform/oversee training for Quality System related topics (e.g. annual GMP training, Change Control, Deviation, and CAPA).
- 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.
- Develop and deliver training programs to ensure staff are knowledgeable about GMP requirements and quality standards.
- Stay current with industry trends, regulatory changes, and best practices, and disseminate this knowledge within the organization.
- Drive continuous improvement initiatives to enhance product quality, efficiency, and compliance.
- Implement and monitor key performance indicators (KPIs) to measure and improve quality performance.
- BS degree in Chemistry or related life sciences discipline. Advanced degree preferred.
- Minimum of 15 years of experience in Quality Assurance for GMP manufacturing in biotech pharmaceutical companies.
- In-depth knowledge of cGMP regulations, QMS, and best industry practices. Additional understanding of GCP, GLP, and pharmacovigilance regulations is a plus.
- Excellent communication and interpersonal skills. Ability to work closely with internal departments involved in GxP activities and external parties (CDMOs, CROs, and vendors).
- Previous experience in hosting successful inspections by regulatory authorities (FDA, EMA etc.) is a plus.
- Strong organization and critical thinking skills with attention to details and accuracy.
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