Global QMS & Audit Lead for Multi‑Site Quality

Orca Bio

United States

Remote

USD 90,000 - 120,000

Full time

14 days+

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Benefits offered by this job

Pre-IPO equity

Annual bonus

Medical insurance

Job summary

Orca Bio is seeking a Senior Specialist, Global QMS to drive the global quality management system across sites and support audits, supplier management, and inspection readiness. You will help ensure GxP compliance and alignment with regulatory expectations while supporting commercial readiness and clinical programs.

You will oversee audit programs, QMR processes, and validation oversight for global enterprise systems.

Qualifications

Bachelor's degree in a scientific or engineering discipline is required.
Minimum 5+ years of QA or Quality Systems in a GxP environment with 2–3 years in a leadership role.
Strong knowledge of FDA, EMA, ICH, ISO 9001, and 21 CFR Parts 210/211/820; EU GMP.
Proven experience leading QMS programs, internal audits, and validation oversight.
Experience managing quality metrics and KPIs across multi-site operations.

Responsibilities

Plan, schedule and execute internal audits across sites and functions.
Develop audit agendas, conduct interviews, review processes and report findings.
Support QMR processes with data collection, analysis and reporting to leadership.
Oversee supplier qualification and management, including risk assessments and audits.
Drive global inspection readiness for FDA, EMA and other authorities.
Provide guidance to site QMR admins for consistent quality systems.
Establish KPIs for global QMS and monitor trends for continuous improvement.
Collaborate with IT to implement QMS enhancements and validated changes.
Review and approve validation documentation for enterprise systems (MasterControl, ERP, Trackwise).
Lead cross-functional efforts to evolve QMS with business needs and regulatory expectations.