Quality Assurance Lead - CSV, QMS & Risk (Biotech)

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 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.