Quality Assurance Manager

Sanguine Biosciences; United States; Remote; USD 110,000 - 115,000; Full time

Job summary

Sanguine Biosciences in the United States is seeking a Quality Assurance Manager to lead the QMS and ensure compliant, scalable processes as the business grows.

You will oversee change control, CSV validation, risk management, supplier quality, audits, and training while driving a culture of continuous improvement across cross-functional teams.

Required: 8+ years in QA for clinical research or pharma, with 3+ years in people leadership and strong FDA/ISO knowledge.

Qualifications

• 8+ years of quality support in clinical research or pharma/biotech development.
• 3+ years in a people leadership role.
• Expertise in change control, deviations, CAPA, risk management, audits, and training.
• Experience with CSV in regulated environments and validation of digital tools.

Responsibilities

• Lead QA staff development, prioritize work, and plan training.
• Own QMS processes end-to-end and ensure FDA/ISO alignment.
• Oversee change control, risk assessment, and validation activities.
• Investigate deviations and supplier quality issues with rigorous root-cause analyses.
• Own CAPA lifecycle and drive continual quality improvements.
• Coordinate internal and client audits and maintain audit readiness.

Skills

QMS governance

CSV validation

GxP software

Deviations handling

CAPA management

Auditing

Training programs

Cross-functional leadership

Education

Bachelor's Degree in Biology, Chemistry, Life Sciences, Engineering

Tools

CSV tools

GxP software

AI-assisted apps

Low-code/no-code

Job description

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.

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; escalated 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: Compensation based on experience education and candidate qualifications.
Range: $110,0000 – 115,000 Annual / Bonus Eligible

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.