VP of Quality & Regulatory Affairs (Pharmaceutical)

Location: Irvine, California, United States; onsite

Salary: $215,000–$245,000 annually, plus an annual bonus based on individual and site performance metrics.

Company

hirify.global is a global pharmaceutical CDMO that develops and manufactures APIs and finished dosage forms across a network of 16 sites on three continents.

What you will do

• Design, build, and implement the strategic framework for the Irvine Quality organization.
• Lead the development, maintenance, and optimization of the Quality Management System.
• Ensure compliance with FDA, EU, ISO, and other applicable regulatory requirements.
• Drive operational consistency, cross-functional alignment, performance measurement, KPIs, and compliance.
• Lead transformational initiatives, change management, organizational design, and operational excellence.
• Build and lead collaborative, high-performance teams through coaching and mentoring.

Requirements

• At least 15 years of experience in progressive senior quality management within biotech, biopharma, or pharmaceutical industries, or 10 years of relevant global quality operations experience.
• Extensive knowledge of quality operations and regulatory affairs.
• Strong understanding of the drug product process.
• Experience with change management, project planning, and capacity planning.
• Bachelor’s degree required; a master’s degree is preferred.
• Clear communication, collaboration, and effective internal and external influencing skills.

Culture & Benefits

• Medical, dental, vision, and life insurance.
• Voluntary accident, hospital, and pet insurance.
• 401(k) plan.
• Paid time off, holidays, sick leave, and personal time.
• Collaborative environment with opportunities for professional growth and long-term development.