Associate QA Systems and Process QMS Director (Biotech)

Location: Alameda, California, United States; up to 10% travel required.

Base salary: $176,000–$251,000 annually, depending on geographic market, qualifications, experience, and internal equity.

Company

hirify.global is a biotechnology company developing medicines and operating within pharmaceutical quality and regulatory environments.

What you will do

• Own the business processes and provide QA support for the eQMS, including deviations, change control, CAPAs, effectiveness checks, and issue escalations.
• Provide guidance on QMS use, process requirements, best practices, and quality-record completeness.
• Own governing procedures and lead continuous improvement of risk-based QMS processes.
• Oversee Veeva enhancements, track QMS trends, and provide metrics and monthly quality-event status reporting.
• Develop risk-based strategies across the GxP landscape, identify and mitigate risks, and drive cross-functional compliance.
• Serve as a subject-matter expert for health authority inspections and audits while supporting CSV and Data Integrity QA activities.

Requirements

• Bachelor’s degree in a relevant discipline with 11 years of related experience, master’s degree with 9 years of related experience, or an equivalent combination of education and experience.
• Knowledge of biotechnology or pharmaceutical operations, cGMPs, health authority regulations, quality systems, and manufacturing processes.
• Experience managing complex quality issues, developing strategies and metrics, improving processes, and leading without direct authority.
• Ability to analyze data, identify weak signals, escalate cumulative risks, and manage competing priorities.
• Strong written, verbal, presentation, organizational, and cross-functional communication skills.
• Ability to work in the Alameda, California office and travel up to 10%.

Nice to have

• Experience in the pharmaceutical or biotech industry and Quality Systems.
• Experience with international or global regulatory requirements.
• Experience participating in regulatory inspections and audits, including presenting or defending functions.

Culture & Benefits

• Collaborative office environment focused on sharing ideas and solutions.
• Equipment including dual monitors and ergonomic chairs.
• 401(k) plan with company contributions, medical, dental, vision, life, disability, and flexible spending benefits.
• Annual bonus eligibility, stock purchase opportunities, and long-term incentives.
• 15 vacation days in the first year, 17 paid holidays, a company-wide winter shutdown, and up to 10 sick days annually.