Head of Quality Assurance

Title: Quality Assurance Leader
Department: GMP Manufacturing (Live Biotherapeutic Products)
Exempt/Non-exempt: Exempt
Job Location: South San Francisco, CA

Description ofRole

The Quality Assurance Leader will be responsible for implementing and scaling the quality function supporting Kanvas Biosciences’ clinical-phase Live Biotherapeutic Product ( LBP ) manufacturing facility. This role balances strategic leadership with hands-on execution and partners closely with Manufacturing, Quality Control, Facilities, and Regulatory Affairs to ensure systems, documentation, and day-to-day decisions align with global regulatory expectations and internal quality standards.

This position is critical to safeguarding product integrity, contamination control, and patient safety.

Key Responsibilities

This role is site-based and highly cross-functional. Youwill:

• Design, implement, and continuously enhance aphase-appropriate QMS aligned with cGMP standards, ISO 13485 ⁄ 17025 requirements, and applicable global regulatory frameworks.
• Own and oversee document control, change management, and record retention programs to ensure data integrity and compliance.
• Review and approve quality-critical documentation including SOPs, master batch records, deviations/investigations, CAPAs, and related quality records.

• Ensure ongoing compliance with FDA and other applicable regulatory requirements for LBP manufacturing.
• Lead internal audit and supplier audit programs using quality risk management tools.
• Serve as inspection host and primary point of communication during regulatory inspections; drive timely and effective resolution of observations.
• Partner with Regulatory Affairs on submissions, product quality documentation, and compliance strategy.

• Review and approve batch records, QC test results, and Certificates of Analysis (CoAs) to support compliant and timely product release.
• Perform release of clinical product for administration in clinical studies.
• Partner with QC to assess out-of-specification ( OOS ) results, deviations, and investigations, and determine appropriate product disposition.
• Track product quality trends and proactively communicate emerging risks to executive leadership.
• Establish, monitor, and report KPIs that reflect quality performance across Manufacturing and QC .
• Proactively identify and implement process improvements, tools, and systems to support compliance and operational efficiency throughout clinical development.

• Lead, mentor, and develop QA team members while fostering aculture of accountability, transparency, and continuous learning.
• Lead departments in the creation and continuous review of training programs to ensure adequacy and compliance.
• Manage the training program and deliver GMP / GDP / GCP training and contamination prevention training.
• Serve as asubject-matter expert and partner to cross-functional teams on quality and compliance matters.

Key Qualifications

We are seeking an experienced QA leader with astrong foundation in regulated manufacturing:

• Bachelor’s or Master’s degree in Microbiology, Biotechnology, Bioprocessing, or arelated scientific field.
• 12 + years of progressive QA experience in fermentation, pharmaceutical, or biotechnology environments.
• 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 , and/or ERP systems.
• Demonstrated success supporting audits, regulatory inspections, and compliance programs.
• Strong organizational and communication skills with the ability to manage multiple priorities and complex issues with high…