Vice President, Quality Assurance - GMP (Pharmaceutical)

Location: Alameda, California, United States; office-based working conditions.

Base pay: $315,500–$366,500 annually, adjusted for geographic market, experience, skills, and internal equity.

Company

hirify.global is a biotechnology and pharmaceutical company developing and commercializing regulated clinical and commercial products.

What you will do

• Lead the enterprise GMP Quality Assurance strategy and oversee the GMP QA department.
• Serve as the final decision authority for clinical and commercial product disposition.
• Lead FDA and other regulatory inspection readiness, vendor audits, and collaboration-partner inspections.
• Oversee GMP Operations QA, Labeling QA, quality agreements, supplier quality, and vendor audit programs.
• Ensure independent Quality oversight of manufacturing, testing, distribution, and external partners.
• Direct investigations, root cause analysis, risk assessments, change controls, CAPAs, metrics, and escalation of product quality risks.

Requirements

• BS/BA with at least 21 years of relevant experience, MS/MA with at least 19 years, PhD with at least 17 years, or an equivalent combination.
• Extensive biotechnology, pharmaceutical, or other regulated-industry experience.
• Significant leadership experience in GMP Quality Assurance and global GMP audit programs.
• Experience with regulatory inspections and external manufacturing and supply networks.
• Comprehensive knowledge of global GMP regulations and Quality systems, with advanced analytical and problem-solving skills.
• Executive communication, risk-based decision-making, organizational transformation, and experience with regulatory agencies and governance bodies.

Nice to have

• Advanced degree in life sciences, engineering, or a related discipline.
• Experience leading Quality organizations through commercialization, expansion, or organizational change.

Culture & Benefits

• Collaborative modern office environment with equipment including dual monitors and ergonomic chairs.
• 401(k) plan with company contributions, medical, dental, and vision coverage.
• Life and disability insurance, flexible spending accounts, and company stock purchase opportunities.
• Annual discretionary bonus program and long-term incentives.
• 15 accrued vacation days in the first year, 17 paid holidays including a company-wide winter shutdown, and up to 10 sick days annually.