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Quality Assurance Manager- Hybrid

Sanguine Biosciences, Inc. · Los Angeles, CA, United States · On Site · Active · Rippling ATS

Job facts

FieldValue
CompanySanguine Biosciences, Inc.
TitleQuality Assurance Manager- Hybrid
Normalized title-
Department / teamQA & Compliance
LocationLos Angeles, CA, United States
Work modelOn Site
Employment typeFull Time
Salary-
Statusactive
ATS providerRippling ATS
Posted / first seen2026-04-02 / 2026-05-29
Changed / last seen2026-06-06 / 2026-06-06

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Linked records

CompanySanguine Biosciences, Inc.
Source2c8d82b1-5e7b-4e9a-9e45-8f919fc1fb76
ATS providerRippling ATS

Description

company About Sanguine Biosciences, Inc. 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. It is an exciting time; our biotech company is growing quickly and needs the best team members to join us. role 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. This role is accountable for oversight and effectiveness of change control, Computer System Validation (CSV), including validation of GxP-relevant software, AI-assisted/low-code/no-code tools, and native-built applications, risk management, supplier/vendor quality, deviation/complaint handling, CAPA, internal auditing, and training. The QA Manager partners cross-functionally to drive a culture of quality, proactive risk management, and continuous improvement. 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. This role is accountable for oversight and effectiveness of change control, Computer System Validation (CSV), including validation of GxP-relevant software, AI-assisted/low-code/no-code tools, and native-built applications, risk management, supplier/vendor quality, deviation/complaint handling, CAPA, internal auditing, and training. The QA Manager partners cross-functionally to drive a culture of quality, proactive risk management, and continuous improvement. Primary Responsibilities: 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. Establish quality objectives and key performance indicators (KPIs); compile, trend, and report quality metrics and corrective actions. Facilitate or contribute to management review inputs (e.g., KPI trends, audit outcomes, CAPA effectiveness, and risk status). Quality Operations (Change Control, CSV/Validation, Risk, CAPA, Complaints) Provide oversight to change control to ensure appropriate impact assessments, risk evaluations, approvals, implementation, and effectiveness checks. Oversee systems/process validation activities, including Computer System Validation (CSV), to ensure fit-for-purpose controls, compliant documentation, data integrity, and sustainable lifecycle management of regulated and quality-impacting tools. Oversee risk-based CSV 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; 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. Document Control & Training Ensure document control processes are followed for creation, review, approval, issuance, change, and archival of controlled documents. Support and strengthen the training program: define role-based curricula, coordinate training events, and monitor completion and effectiveness. Maintain and/or oversee maintenance of training records to ensure audit-ready documentation. Audits & Inspection Readiness 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 on-time. Conduct or oversee supplier/vendor audits and qualification activities; ensure supplier performance is monitored and issues are escalated and resolved. Cross-Functional Partnership Partner with Operations, Clinical/Research, Product/Engineering (as applicable), and leadership to integrate quality into daily execution and decision-making. Provide quality guidance during process development, supplier selection/management, and implementation of new tools or workflows, including AI-assisted, low-code/no-code, and native-built applications used in quality or operational processes. 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. Position Requirements: 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. 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; active continuing education a plus. Strong computer literacy, excellent written and verbal communication skills, and strong organizational/time management skills. Comfortable operating with autonomy, influencing without authority, and making sound quality judgments under time constraints. Salary: $110,000 to $115,000 annually plus an annual performance based bonus Sanguine Biosciences is proud to provide equal employment opportunities to all qualified individuals without regard to race, color, religion, sex, gender identity, sexual orientation, pregnancy, age, national origin, physical or mental disability, military or veteran status, genetic information, or any other protected classification. Minorities, women, LGBTQ candidates, Veterans, and individuals with disabilities are encouraged to apply.Sanguine Biosciences is proud to provide equal employment opportunities to all qualified individuals without regard to race, color, religion, sex, gender identity, sexual orientation, pregnancy, age, national origin, physical or mental disability, military or veteran status, genetic information, or any other protected classification. Minorities, women, LGBTQ candidates, Veterans, and individuals with disabilities are encouraged to apply.

Full job record

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TitleQuality Assurance Manager- Hybrid
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Location TextLos Angeles, CA, United States
DepartmentQA & Compliance
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RegionCA
CityLos Angeles
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First Seen At2026-05-29 07:07:13Z
Last Seen At2026-06-06 19:46:54Z
Last Checked At2026-06-06 19:46:54Z
Last Changed At2026-06-06 19:46:54Z
Inactive At—
Source Posted At2026-04-02 13:47:00Z
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      "role": "<meta><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><br></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><b><strong style=\"white-space:pre-wrap;\">About the Role: </strong></b></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:justify;\"><span style=\"white-space:pre-wrap;\">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. This role is accountable for oversight and effectiveness of change control, Computer System Validation (CSV), including validation of GxP-relevant software, AI-assisted/low-code/no-code tools, and native-built applications, risk management, supplier/vendor quality, deviation/complaint handling, CAPA, internal auditing, and training. 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This role is accountable for oversight and effectiveness of change control, Computer System Validation (CSV), including validation of GxP-relevant software, AI-assisted/low-code/no-code tools, and native-built applications, risk management, supplier/vendor quality, deviation/complaint handling, CAPA, internal auditing, and training. The QA Manager partners cross-functionally to drive a culture of quality, proactive risk management, and continuous improvement.</span></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:justify;\"><span style=\"white-space:pre-wrap;\">&nbsp;</span></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:justify;\"><b><strong style=\"white-space:pre-wrap;\">Primary Responsibilities:</strong></b></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:justify;\"><span style=\"white-space:pre-wrap;\">&nbsp;</span></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:justify;\"><u><span style=\"text-decoration:underline;white-space:pre-wrap;\">Leadership &amp; QMS Governance</span></u></p><ul data-pattern=\"discCircleSquare\" data-depth=\"1\" style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin:8px 0px;line-height:1.6;padding:0px 0px 0px 32px;list-style-type:disc;\"><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;\"><span style=\"white-space:pre-wrap;\">Lead and develop QA staff through coaching, workload prioritization, performance feedback, and training plans.</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;\"><span style=\"white-space:pre-wrap;\">Own assigned QMS processes end-to-end, ensuring procedures are current, effective, and aligned to applicable FDA/ISO expectations.</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;\"><span style=\"white-space:pre-wrap;\">Promote organizational awareness of the Quality System; deliver and/or coordinate quality training, tools, and best practices.</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;\"><span style=\"white-space:pre-wrap;\">Establish quality objectives and key performance indicators (KPIs); compile, trend, and report quality metrics and corrective actions.</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;\"><span style=\"white-space:pre-wrap;\">Facilitate or contribute to management review inputs (e.g., KPI trends, audit outcomes, CAPA effectiveness, and risk status).</span></li></ul><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:justify;\"><span style=\"white-space:pre-wrap;\">&nbsp;</span><u><span style=\"text-decoration:underline;white-space:pre-wrap;\">Quality Operations (Change Control, CSV/Validation, Risk, CAPA, Complaints)</span></u></p><ul data-pattern=\"discCircleSquare\" data-depth=\"1\" style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin:8px 0px;line-height:1.6;padding:0px 0px 0px 32px;list-style-type:disc;\"><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;\"><span style=\"white-space:pre-wrap;\">Provide oversight to change control to ensure appropriate impact assessments, risk evaluations, approvals, implementation, and effectiveness checks.</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;\"><span style=\"white-space:pre-wrap;\">Oversee systems/process validation activities, including Computer System Validation (CSV), to ensure fit-for-purpose controls, compliant documentation, data integrity, and sustainable lifecycle management of regulated and quality-impacting tools.</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;\"><span style=\"white-space:pre-wrap;\">Oversee risk-based CSV 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.</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;\"><span style=\"white-space:pre-wrap;\">Lead investigations for deviations, nonconformances, and complaints; ensure root cause analyses are rigorous, timely, and appropriately documented.</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;\"><span style=\"white-space:pre-wrap;\">Own or oversee CAPA lifecycle management, including initiation, action planning, implementation, and verification of effectiveness.</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;\"><span style=\"white-space:pre-wrap;\">Engineer solutions to address product, data, and process quality issues; drive continual improvement projects and standardization across teams.</span></li></ul><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:justify;\"><u><span style=\"text-decoration:underline;white-space:pre-wrap;\">Document Control &amp; Training</span></u></p><ul data-pattern=\"discCircleSquare\" data-depth=\"1\" style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin:8px 0px;line-height:1.6;padding:0px 0px 0px 32px;list-style-type:disc;\"><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;\"><span style=\"white-space:pre-wrap;\">Ensure document control processes are followed for creation, review, approval, issuance, change, and archival of controlled documents.</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;\"><span style=\"white-space:pre-wrap;\">Support and strengthen the training program: define role-based curricula, coordinate training events, and monitor completion and effectiveness.</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;\"><span style=\"white-space:pre-wrap;\">Maintain and/or oversee maintenance of training records to ensure audit-ready documentation.</span></li></ul><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:justify;\"><span style=\"white-space:pre-wrap;\">&nbsp;</span><u><span style=\"text-decoration:underline;white-space:pre-wrap;\">Audits &amp; Inspection Readiness</span></u></p><ul data-pattern=\"discCircleSquare\" data-depth=\"1\" style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin:8px 0px;line-height:1.6;padding:0px 0px 0px 32px;list-style-type:disc;\"><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;\"><span style=\"white-space:pre-wrap;\">Plan and execute internal audits; manage the annual audit program and ensure timely closure of audit findings.</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;\"><span style=\"white-space:pre-wrap;\">Host, co-host, and support client audits; coordinate readiness activities and ensure responses are accurate, complete, and on-time.</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;\"><span style=\"white-space:pre-wrap;\">Conduct or oversee supplier/vendor audits and qualification activities; 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ability to interpret requirements and translate them into practical processes.</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;\"><span style=\"white-space:pre-wrap;\">Working knowledge of 21 CFR Part 11, electronic records/electronic signatures expectations, and risk-based validation approaches for digital systems.</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;\"><span style=\"white-space:pre-wrap;\">Regulatory/quality certifications (ASQ/SQA) and/or Lean/Six Sigma (Green Belt/Black Belt) preferred; active continuing education a plus.</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;\"><span style=\"white-space:pre-wrap;\">Strong computer literacy, excellent written and verbal communication skills, and strong organizational/time management skills.</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;\"><span style=\"white-space:pre-wrap;\">Comfortable operating with autonomy, influencing without authority, and making sound quality judgments under time constraints.</span></li></ul><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><br></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><b><strong style=\"white-space:pre-wrap;\">Salary:</strong></b><span style=\"white-space:pre-wrap;\"> $110,000 to $115,000 annually plus an annual performance based bonus</span></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><br></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><i><em style=\"color:black;font-size:9pt;white-space:pre-wrap;\">Sanguine Biosciences is proud to provide equal employment opportunities to all qualified individuals without regard to race, color, religion, sex, gender identity, sexual orientation, pregnancy, age, national origin, physical or mental disability, military or veteran status, genetic information, or any other protected classification. Minorities, women, LGBTQ candidates, Veterans, and individuals with disabilities are encouraged to apply.Sanguine Biosciences is proud to provide equal employment opportunities to all qualified individuals without regard to race, color, religion, sex, gender identity, sexual orientation, pregnancy, age, national origin, physical or mental disability, military or veteran status, genetic information, or any other protected classification. Minorities, women, LGBTQ candidates, Veterans, and individuals with disabilities are encouraged to apply.</em></i></p>",
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