Global QMS Compliance & Audit Lead

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

Benefits offered by this job

Pre-IPO equity

Annual bonus

Medical, dental, and vision benefits

PTO

401(k)

Life and AD&D

Parental leave

Subsidized lunches and snacks

Job summary

Orca Bio is seeking a Senior Specialist, Global QMS to implement and oversee the company’s global quality management system across sites. You will lead internal audits, supplier management, and inspection readiness to support manufacturing of cell therapies and commercial readiness.

You will collaborate with cross-functional teams to ensure compliance with GxP and regulatory expectations, drive KPI-based improvements, and work with IT on QMS enhancements and validations across MasterControl,

Qualifications

• Bachelor's degree in a scientific or engineering discipline required.
• Minimum 5+ years of QA/QMS experience in a GxP-regulated environment with at least 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 programs: internal audits, QMR, supplier management, validation oversight.
• Experience with electronic QMS systems and IT collaboration.

Responsibilities

• Plan, schedule and execute internal audits across all sites and functions.
• Develop audit agenda, 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 audits.
• Drive global inspection readiness for FDA, EMA and other health authorities inspections.
• Provide oversight to site QMR admins for consistent QMS implementation.
• Establish and monitor QMS KPIs; drive data-driven improvements.
• Collaborate with IT to define QMS enhancements and validation.
• Review and approve validation documentation for enterprise systems.

Skills

Leadership

Analytical skills

Communication skills

Organizational skills

Education

Bachelor’s degree in science or engineering

Advanced degree preferred

Tools

MasterControl

Trackwise

ERP systems

Job description

Orca Bio is seeking a Senior Specialist, Global QMS to implement and oversee the company’s global quality management system across sites. You will lead internal audits, supplier management, and inspection readiness to support manufacturing of cell therapies and commercial readiness.

You will collaborate with cross-functional teams to ensure compliance with GxP and regulatory expectations, drive KPI-based improvements, and work with IT on QMS enhancements and validations across MasterControl,