Global QMS Senior Specialist - Audit & Compliance Leader

Orca Bio; Sacramento (CA); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Pre-IPO equity

Annual bonus

Health benefits

PTO

401(k)

Lunch on-site

Job summary

Orca Bio is seeking a Senior Specialist, Global QMS to implement and expand the quality management system across sites. You will lead internal audits, supplier management, and inspection readiness to ensure GxP compliance and regulatory alignment for cell therapy manufacturing.

This role supports commercial readiness and clinical programs by managing audits, resolving supplier quality issues, and ensuring consistent quality system application across Orca Bio sites.

Qualifications

• Excellent organizational and analytical abilities to manage complex quality systems.
• Strong written and verbal communication for cross-functional collaboration.
• Ability to influence and drive improvement across multi-site teams.

Responsibilities

• Plan, schedule and execute internal audits across all sites and functions.
• Develop audit agendas, interview processes, and generate audit reports.
• Support global QMS processes, KPIs, and data-driven quality improvements.
• Oversee supplier qualification and management, including risk assessments and audits.
• Drive global inspection readiness for FDA, EMA, and other health authorities.

Skills

Organizational skills

Analytical skills

Communication skills

Education

Bachelor's degree in scientific or engineering field

Advanced degree preferred

Job description

Orca Bio is seeking a Senior Specialist, Global QMS to implement and expand the quality management system across sites. You will lead internal audits, supplier management, and inspection readiness to ensure GxP compliance and regulatory alignment for cell therapy manufacturing.

This role supports commercial readiness and clinical programs by managing audits, resolving supplier quality issues, and ensuring consistent quality system application across Orca Bio sites.