Kanvas Biosciences · 3 weeks ago
Head of Quality Assurance
South San Francisco, CA
Full-time
Onsite
Director/Executive
$200K/yr - $260K/yr
12+ years expKanvas Biosciences is a pioneering microbiome therapeutics company developing innovative drug solutions. They are seeking a highly skilled Quality Assurance Leader responsible for implementing and growing the quality function to support their advanced Live Biotherapeutic Product manufacturing facility, ensuring compliance with regulatory standards and maintaining product integrity.
BiotechnologyLife Science
Hiring Manager
Colleen Massey
Responsibilities
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
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 resulting
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
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
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
Qualification
Required
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, regulatory inspections, and compliance programs
Strong leadership, excellent communication and organizational skills with the ability to operate strategically and roll up sleeves when necessary
Ability to provide cross-functional team leadership to maintain alignment and to set and meet collective operational goals. Strong leadership skills
Preferred
Familiarity with microbial fermentation systems
Knowledge of quality risk management and contamination control strategies in microbial manufacturing environments
Certification in Six Sigma, Lean, or equivalent continuous improvement methodologies
Company
Kanvas Biosciences
Mapping interactions foundational to therapeutic discovery and human health.
11-50 employees
H1B Sponsorship
Kanvas Biosciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2022 (2)
Funding
Current Stage
Early StageTotal Funding
$28.41MKey Investors
DCVC
2024-07-01Series A· $12.5M
2024-03-18Seed· $3.91M
2023-06-22Seed· $12M
Leadership Team
Hao Shi
Chief Technology Officer
Lee Swem
Chief Development Officer
Recent News
2025-05-04
2025-05-04
Company data provided by crunchbase