Global QMS Lead – Quality Assurance & Compliance

Remote; San Francisco (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Orca Bio is seeking a Senior Specialist, Global QMS to implement and expand our GxP quality management system across sites. You will lead internal audits, supplier management, and readiness for FDA/EMA inspections while guiding validation and documentation across enterprise systems.

You will drive QMS KPIs, data-driven improvements and cross-functional collaboration with IT and site leadership to sustain regulatory compliance and quality excellence.

Qualifications

• Bachelor's degree in a scientific or engineering discipline.
• 5+ years of QA or Quality Systems experience in a GxP-regulated environment with 2–3 years in a leadership role.
• Strong knowledge of FDA, EMA, ICH, ISO 9001, 21 CFR Parts 210/211/820, EU GMP.
• Proven experience leading QMS initiatives, internal audits, supplier management, and validation oversight.
• Experience with electronic QMS systems and multi-site quality operations.

Responsibilities

• Plan, schedule and execute internal audits across all sites and functions.
• Develop audit agendas, conduct interviews, review processes and generate audit reports.
• Support the global QMR process with data collection, analysis and reporting to senior leadership.
• Support supplier qualification and management, including risk assessments and supplier audits.
• Drive global inspection management for FDA, EMA inspections and other health authorities.
• Oversee site QMR administrators for consistent QMS implementation across Orca Bio sites.
• Establish and monitor global QMS KPIs and drive data-driven improvements.
• Partner with IT for QMS enhancements, defining requirements and validation.
• Review and approve validation docs for enterprise systems (MasterControl, ERP, TrackWise).
• Collaborate with cross-functional/site leadership to drive continuous improvement.

Skills

Quality Assurance

Quality Systems

GxP Regulation

Audit Leadership

QA Metrics

Validation Oversight

Regulatory Compliance

Cross-functional

QMS Tools

IT Collaboration

Education

Bachelor's degree

Advanced degree

Tools

MasterControl

ERP Systems

TrackWise

Job description

Orca Bio is seeking a Senior Specialist, Global QMS to implement and expand our GxP quality management system across sites. You will lead internal audits, supplier management, and readiness for FDA/EMA inspections while guiding validation and documentation across enterprise systems.

You will drive QMS KPIs, data-driven improvements and cross-functional collaboration with IT and site leadership to sustain regulatory compliance and quality excellence.