Head of Quality Assurance

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 of Role

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. You will:

Quality Management System (QMS)
Design, implement, and continuously enhance a phase-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.
Compliance & Regulatory Oversight
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.
Batch Release & Product Quality
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.
Continuous Improvement
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.
Training & Leadership
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 adequacy and compliance.
Manage the training program 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.

Key Qualifications

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

Bachelor's or Master's degree in Microbiology, Biotechnology, Bioprocessing, or a related 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 attention to detail.
Proven ability to provide cross-functional leadership, maintain alignment, and deliver collective operational goals (strategic and hands-on).

Preferred Skills

Familiarity with microbial fermentation systems.
Experience with quality risk management and contamination control strategies in microbial manufacturing environments.
Six Sigma, Lean, or equivalent continuous improvement certification.

Our Values

We hire good people who are also great scientists. We value integrity, honesty, dedication, and sportsmanship.
We think like explorers. We embrace new frontiers with preparation, creativity, and effort.
We have a steadfast commitment to the team. We support each other and believe our collective talent can solve any problem.
We believe there is power in diversity. We celebrate diverse backgrounds and viewpoints as strengths that fuel discovery and culture.
How to Apply

Please send your resume or CV to colleen@kanvasbio.com