Sanguine Biosciences INC

Quality Assurance Manager- Hybrid

Los Angeles, CA

Sponsorship not specified$110k-$115kDetected 26 days ago

AuditingProcess ImprovementClinical TrialsClinical ResearchFDA RegulatoryResearchLeadershipCommunicationTime ManagementMentoringGxP

About the role

The Quality Assurance Manager provides day-to-day leadership for key Quality Management System (QMS) processes and the Quality team, ensuring continued suitability, compliance, and scalability of the QMS as the business grows.
Primary Responsibilities: The Quality Assurance Manager provides day-to-day leadership for key Quality Management System (QMS) processes and the Quality team, ensuring continued suitability, compliance, and scalability of the QMS as the business grows.
Establish quality objectives and key performance indicators (KPIs); compile, trend, and report quality metrics and corrective actions.

The QA Manager partners cross-functionally to drive a culture of quality, proactive risk management, and continuous improvement.
Leadership & QMS Governance Lead and develop QA staff through coaching, workload prioritization, performance feedback, and training plans.
Own assigned QMS processes end-to-end, ensuring procedures are current, effective, and aligned to applicable FDA/ISO expectations.
Promote organizational awareness of the Quality System; deliver and/or coordinate quality training, tools, and best practices.
Lead investigations for deviations, nonconformances, and complaints; ensure root cause analyses are rigorous, timely, and appropriately documented.
Own or oversee CAPA lifecycle management, including initiation, action planning, implementation, and verification of effectiveness.
Engineer solutions to address product, data, and process quality issues; drive continual improvement projects and standardization across teams.

Bachelor's Degree in Biology, Chemistry, Life Sciences, Engineering, or related field (required).
8+ years of experience in quality supporting clinical research and/or pharmaceutical/biotech development
advanced degree may substitute for a portion of experience.
3+ years of experience leading others (people leadership, team lead, or mentorship/accountability for work output).
Demonstrated expertise in QMS processes: change control, deviations/nonconformances, complaints, CAPA, risk management, supplier quality, audits, and training.

change control, deviations/nonconformances, complaints, CAPA, risk management, supplier quality, audits, and training.
Demonstrated experience with Computer System Validation (CSV) in a regulated environment, including risk-based validation of software, spreadsheets, SaaS platforms, and workflow tools.
Experience validating AI-assisted, low-code/no-code, and native-built applications, with the ability to assess 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
ability to interpret requirements and translate them into practical processes.
Working knowledge of 21 CFR Part 11, electronic records/electronic signatures expectations, and risk-based validation approaches for digital systems.
Regulatory/quality certifications (ASQ/SQA) and/or Lean/Six Sigma (Green Belt/Black Belt) preferred

Minorities, women, LGBTQ candidates, Veterans, and individuals with disabilities are encouraged to apply.

Sanguine Biosciences is accelerating personalized medicine research by empowering patients with their healthcare data and making it as easy as possible for them to participate in the medical research process.
We partner with patients and pharmaceutical companies to accelerate precision medicine R&D by securely and efficiently collecting and providing patient samples and relevant health data.

We are helping thousands of researchers at 20 of the top 40 global pharmaceutical and biotechnology companies increase the speed and quality at which they are conducting their research.

This listing is sourced directly from Sanguine Biosciences INC's careers page and normalized into a canonical job model.