Quality Assurance Manager

Sanguine Biosciences, Inc.; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

Sanguine Biosciences, Inc. is seeking a Quality Assurance Manager to lead the QMS and Quality team, ensuring continued suitability, compliance, and scalability of quality processes as the business grows.

You will own change control, CSV validation (including AI-assisted/low-code/no-code tools and native-built applications), risk management, supplier quality, deviation handling, CAPA, audits, and training, partnering across functions to drive a culture of quality and continuous improvement.

Qualifications

• Bachelor's degree in Biology, Chemistry, Life Sciences or related field.

Responsibilities

• Lead and develop QA staff through coaching, workload prioritization, and training plans.
• Own assigned QMS processes end-to-end and ensure procedures are current and compliant with FDA/ISO expectations.
• Deliver QA training, tools, and best practices; establish KPIs and report quality metrics and CAPA effectiveness.
• Provide oversight of change control, risk assessments, approvals, and effectiveness checks.
• Oversee CSV/validation activities for GxP-relevant software and tools, including AI/no-code solutions.
• Lead investigations for deviations, nonconformances, and complaints; manage CAPA lifecycle.
• Ensure document control for creation, review, approval, issuance, and archival of controlled docs.
• Plan and execute internal audits and host client audits; coordinate readiness activities.
• Partner with Operations, Product/Engineering and leadership to integrate quality into daily execution and decision-making.

Skills

QA leadership

Quality System governance

CSV/Validation

Risk management

CAPA & Deviations handling

Audits & Inspection readiness

Cross-functional collaboration

Education

Bachelor's Degree in Biology, Chemistry, Life Sci

Tools

AI-assisted applications

Low-code/no-code tools

Native-built applications

Job description

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

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; elevate emerging issues and recommend pragmatic, compliant paths forward.

Position Requirements

Bachelor's Degree in Biology, Chemistry, Life Sci