QA Systems and Process Manager (GxP)

Location: Alameda, California, United States; up to 5% travel required.

Base salary: $145,000–$184,000 per year.

Company

hirify.global is a biotechnology company developing medicines and operating in a regulated pharmaceutical environment.

What you will do

• Provide independent, risk-based QA oversight for GxP-regulated computerized systems across IT, Clinical Data Management, and other functions.
• Review and approve risk assessments, validation plans and tests, user acceptance tests, evidence, summary reports, change controls, and deviations.
• Author and execute CSV implementation plans, manage project and change timelines, and drive issues to resolution.
• Evaluate incidents, deviations, and CAPAs to maintain validated states and escalate compliance risks.
• Generate reports and metrics, track actions, maintain guidance and user documentation, and improve monitoring and user issue management.
• Support internal and external audits and inspections, including the transition from Computer System Validation to Computer Software Assurance.

Requirements

• Bachelor’s degree in science or a related field with 7 years of related experience, or an equivalent combination of education and experience.
• At least 5 years of experience with GxP-validated applications in a pharmaceutical or regulated environment.
• Experience with quality and regulatory business processes, including hands-on implementation of GxP computerized systems and maintenance of their validated state.
• Strong process improvement, business, technology, communication, presentation, collaboration, and customer-oriented solution skills.
• Ability to explain ideas in both technical and user-friendly language and work with confidential data.
• Deep understanding of applicable regulatory guidelines, including 21 CFR Part 11, EU Annex 11, ICH GCP/GLP, and data integrity principles.
• General knowledge of databases and computer networking, plus working knowledge or experience with SaaS systems.
• Ability to prioritize and drive results.

Nice to have

• Experience or understanding of Computer Software Assurance.

Culture & Benefits

• Onsite work in a modern collaborative office with dual monitors and ergonomic chairs.
• Employee benefits include 401(k) contributions, medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• Eligible employees may receive a discretionary annual bonus, company stock purchase opportunities, and long-term incentives.
• Benefits include 15 accrued vacation days in the first year, 17 paid holidays including a company-wide winter shutdown, and up to 10 sick days annually.
• No supervisory responsibilities are assigned to this role.