Full-Time
Quality Assurance Manager
Updated on 9/11/2026
Sanguine Biosciences
Compensation Overview
$110k - $115k/yr
+ Annual performance-based bonus
Los Angeles, CA, USA
Hybrid
Hybrid work arrangement.
Bachelor's
Category
 Biology & Biotech (1) |
|---|
Required Skills
Six Sigma
Quality Assurance (QA)
Risk Management
Requirements
- A bachelor's degree in Biology, Chemistry, Life Sciences, Engineering, or a related field is required.
- At least 8 years of experience in quality supporting clinical research and/or pharmaceutical or biotechnology development is required; an advanced degree may substitute for a portion of the experience.
- At least 3 years of experience leading others through people leadership, team leadership, or mentorship and accountability for work output is required.
- Demonstrated expertise in Quality Management System processes, including change control, deviations or nonconformances, complaints, corrective and preventive action, risk management, supplier quality, audits, and training.
- Demonstrated experience with Computer System Validation in a regulated environment, including risk-based validation of software, spreadsheets, Software as a Service platforms, and workflow tools.
- Experience validating AI-assisted, low-code/no-code, and native-built applications, including assessing intended use, system risk, testing rigor, data integrity, and change-control requirements.
- Experience compiling and trending quality metrics and driving data-based continuous improvement.
- Strong working knowledge of FDA and ISO concepts relevant to the organization, with the ability to interpret requirements and translate them into practical processes.
- Working knowledge of 21 CFR Part 11 and electronic-records and electronic-signatures expectations, as well as risk-based validation approaches for digital systems.
- Strong computer literacy and strong organizational and time-management skills.
- Ability to operate autonomously, influence without authority, and make sound quality judgments under time constraints.
Responsibilities
- Lead and develop QA staff through coaching, workload prioritization, performance feedback, and training plans.
- Own assigned Quality Management System processes end-to-end, ensuring procedures are current, effective, and aligned with applicable FDA and ISO expectations.
- Promote organizational awareness of the Quality System and deliver or coordinate quality training, tools, and best practices.
- Establish quality objectives and key performance indicators; compile, trend, and report quality metrics and corrective actions.
- Facilitate or contribute to management-review inputs, including key performance indicator trends, audit outcomes, corrective and preventive action effectiveness, and risk status.
- Provide oversight of change control, including impact assessments, risk evaluations, approvals, implementation, and effectiveness checks.
- Oversee systems and process validation activities, including Computer System Validation, to ensure fit-for-purpose controls, compliant documentation, data integrity, and sustainable lifecycle management of regulated and quality-impacting tools.
- Oversee risk-based Computer System Validation activities for GxP-relevant software, spreadsheets, databases, workflow tools, AI-assisted applications, low-code/no-code solutions, and native-built applications, including intended-use assessment, risk assessment, traceability, testing, deviation handling, and validation-summary reporting.
- Lead investigations for deviations, nonconformances, and complaints, ensuring rigorous, timely, and appropriately documented root-cause analyses.
- Own or oversee the corrective and preventive action lifecycle, including initiation, action planning, implementation, and verification of effectiveness.
- Engineer solutions for product, data, and process quality issues and drive continual-improvement projects and standardization across teams.
- Ensure document-control processes are followed for creation, review, approval, issuance, change, and archival of controlled documents.
- Define role-based training curricula, coordinate training events, and monitor completion and effectiveness.
- Maintain or oversee training records to ensure audit-ready documentation.
- Plan and execute internal audits, manage the annual audit program, and ensure timely closure of audit findings.
- Host, co-host, and support client audits; coordinate readiness activities and ensure responses are accurate, complete, and timely.
- Conduct or oversee supplier and vendor audits and qualification activities; monitor supplier performance and ensure issues are escalated and resolved.
- Partner with Operations, Clinical/Research, Product/Engineering, and leadership to integrate quality into daily execution and decision-making.
- Provide quality guidance during process development, supplier selection and management, and implementation of new tools or workflows.
- Partner with Product/Engineering and business stakeholders to define fit-for-purpose validation controls, change-management expectations, and lifecycle oversight for internally developed applications and automation tools.
- Communicate quality risks clearly to stakeholders, escalate emerging issues, and recommend pragmatic, compliant paths forward.
Desired Qualifications
- Regulatory or quality certifications such as ASQ or SQA are preferred.
- Lean/Six Sigma Green Belt or Black Belt certification is preferred.
- Active continuing education is a plus.
- Excellent written and verbal communication skills are desired.