Head of Quality Assurance

This range is provided by Kanvas Biosciences. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$/yr - $/yr

Kanvas Biosciences is a pioneering microbiome therapeutics company developing the world’s first spatial microbiome drug screening, discovery, and manufacturing platform. Our mission is to unlock the microbiome as a druggable organ system to revolutionize the treatment of microbiome-associated diseases. With cutting-edge imaging, microbial ecology, and biomanufacturing expertise, our team is leading the development of next‑generation live biotherapeutic products (LBPs).

We are seeking a highly skilled Quality Assurance Leader who will be responsible for implementing and growing the quality function supporting our advanced Live Biotherapeutic Product clinical‑phase manufacturing facility. This leader will balance strategic vision with hands‑on execution, working closely with Manufacturing, Quality Control, Facilities, and Regulatory Affairs to ensure all operational activities, documentation, and decision‑making align with global regulatory expectations and internal quality standards.

This role plays a critical part in safeguarding product integrity, contamination control, and patient safety.

• Quality Management Systems (QMS)
• Design, implement, and continuously enhance a robust QMS aligned with phase‑appropriate cGMP standards, ISO 13485/17025 requirements, and relevant global regulatory frameworks.
• Oversee document control, change management, and record‑retention programs to maintain data integrity and compliance.
• Lead the review and approval of SOPs, master batch records, deviations/investigations, CAPAs, and other quality‑critical documentation.
• Compliance & Regulatory Oversight
• Ensure ongoing compliance with FDA and other applicable regulatory bodies for LBP manufacturing.
• Manage the internal and supplier audit programs applying quality risk management tools.
• Lead regulatory inspections including acting as host and serving as the point of communication to the company throughout the inspection.
• Drive timely resolution of audit/inspection observations.
• Collaborate with Regulatory Affairs on submissions, product quality documentation, and compliance strategy.
• Batch Release & Product Quality
• Review and approve batch records, QC test results, and COAs to support timely and compliant product release.
• Perform release of clinical product for administration in clinical studies.
• Work closely with QC to assess OOS results, deviations, and related investigations; determine appropriate product disposition.
• Track product quality trends and proactively communicate emerging risks to executive leadership.
• Establish, monitor, and report on KPIs that reflect quality performance across manufacturing and QC functions.
• Proactively identify processes, tools, systems, etc. to ensure continued compliance and corporate efficiency throughout clinical development.
• Lead, mentor, and develop QA team members while fostering a culture of accountability, transparency, and continuous learning.
• Lead departments in the creation and continuous review of training programs to ensure the adequacy of the training program.
• Manage the training and deliver GMP/GDP/GCP training and contamination prevention training.
• Serve as a subject‑matter expert and partner to cross‑functional teams on quality and compliance matters.

• Bachelor’s or Master’s degree in Microbiology, Biotechnology, Bioprocessing, or a related scientific field.
• 12+ years of progressive QA experience within fermentation, pharmaceutical, or biotechnology environments.
• Ability to balance multiple priorities and complex issues using logical, analytical, and efficient processes with a high level of attention to detail and quality of work.
• Deep knowledge of cGMP, GLP, ICH, ISO 13485/17025, and FDA regulatory expectations.
• Strong understanding of ALCOA+ and data integrity principles.
• Experience implementing or managing electronic QMS, LIMS, or ERP systems.
• Demonstrated experience supporting audits,…