Associate Director, Computer Systems Assurance (Quality)

Location: Brisbane, California — onsite

Salary: $190,000–$217,000 per year

Company

hirify.global is a clinical-stage biopharmaceutical company developing targeted protein degradation medicines and small-molecule therapies for cancer and immune disorders.

What you will do

• Own and advance the computer systems assurance and computerized system validation programs.
• Establish and maintain a risk-based CSA framework for GxP-regulated systems.
• Qualify and validate SaaS and cloud-hosted platforms supporting clinical development, quality operations, manufacturing oversight, and regulatory submissions.
• Translate regulatory expectations into pragmatic, fit-for-purpose validation approaches.
• Assess, validate, and maintain GxP-critical systems in a compliant state.
• Work with Quality, IT, Regulatory Affairs, CMC, Clinical Operations, and external vendors.

Requirements

• Deep technical knowledge of GxP computerized systems.
• Practical experience with SaaS and cloud-based platform qualification.
• Experience with CSA and CSV activities.
• Knowledge of FDA computer software assurance guidance, GAMP 5 Second Edition, 21 CFR Part 11, and Annex 11.
• Ability to work onsite in Brisbane, California.

Culture & Benefits

• Work within a lean, virtual drug development infrastructure.
• Use a curated ecosystem of SaaS and cloud-hosted platforms.
• Apply a risk-based and science-driven approach to computer systems assurance.
• Collaborate across Quality, IT, Regulatory Affairs, CMC, Clinical Operations, and external vendors.