Quality Assurance Manager

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.

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.

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.

• 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).

• 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.

• 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.

• Plan and execute internal audits; manage the annual audit program and ensure timely…