Remote Senior QMS Leader — Global Audits

Orca Bio; United States; Remote; USD 90,000 - 120,000; Full time

Benefits offered by this job

Pre-IPO equity

Annual bonus

Benefits package

Job summary

Orca Bio is seeking a Senior Specialist, Global QMS to implement and scale the quality management system across sites, leading internal audits, supplier management, and inspection readiness. You will partner with cross‑functional teams to ensure GxP compliance and drive data‑driven quality improvements.

This remote‑friendly role offers a path from pre‑IPO to commercial readiness, with competitive compensation, pre‑IPO equity, and a comprehensive benefits package.

Qualifications

• Bachelor’s degree in a scientific or engineering discipline; advanced degree preferred.
• 5+ years QA/QMS 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.
• Experience leading internal audits, QMR, supplier management, and validation oversight.

Responsibilities

• Plan, schedule and execute internal audits across sites.
• Develop audit agendas, conduct interviews, review processes.
• Support the global Quality Management Review (QMR) process with data collection and reporting.
• Support the supplier qualification and management program with risk assessments and audits.
• Drive global inspection management activities for FDA, EMA inspections.
• Provide oversight to site QMR administrators for consistent QMS implementation.
• Establish and monitor global QMS KPIs and quality metrics.
• Collaborate with IT to implement QMS enhancements and validate changes.
• Review and approve validation documents for enterprise systems.

Skills

QMS governance

Inspection readiness

System validation

Quality metrics KPIs

Cross-functional leadership

Education

Bachelor's degree in science/engineering

Tools

MasterControl

TrackWise

ERP systems

Job description

Orca Bio is seeking a Senior Specialist, Global QMS to implement and scale the quality management system across sites, leading internal audits, supplier management, and inspection readiness. You will partner with cross‑functional teams to ensure GxP compliance and drive data‑driven quality improvements.

This remote‑friendly role offers a path from pre‑IPO to commercial readiness, with competitive compensation, pre‑IPO equity, and a comprehensive benefits package.