Director, Good Manufacturing Processes, Quality Assurance (GMP QA)

Location: South San Francisco, California, United States. Onsite work is required at headquarters four days per week.

Salary: $200,000–$247,000 per year.

Company

hirify.global is a precision medicine oncology company developing targeted small-molecule therapies and antibody-drug conjugates for molecularly defined solid tumors.

What you will do

• Lead strategic and operational GMP QA oversight for drug products and biologics from toxicology through Phase 3.
• Provide Quality leadership for clinical trial materials, development-stage manufacturing, analytical activities, and pharmaceutical development.
• Review and approve deviations, CAPAs, change controls, protocols, reports, batch records, and final product release or rejection.
• Oversee CDMOs, CROs, testing laboratories, and other GxP service providers, including quality agreements, audits, qualification, and risk assessments.
• Support regulatory submissions, inspections, partner audits, due diligence, and inspection readiness.
• Develop and maintain SOPs and quality systems covering product release, design control, change management, technology transfer, and development QA.

Requirements

• BS degree in life sciences, chemistry, engineering, or a related discipline; an MS, PhD, or PharmD is strongly preferred.
• At least 12 years of relevant biopharmaceutical Quality Assurance experience, including 8 years supporting development-stage programs.
• At least 5 years of direct GxP experience and 3 years supporting computer systems validation.
• Deep knowledge of GMP regulations and quality standards, including FDA, EMA, PMDA, ICH, EU Annexes, GAMP5, ISO 9001, and ISO 27001.
• Experience with clinical manufacturing, analytical method development and validation, technology transfer, pharmaceutical development, and oversight of external service providers.
• Ability to work onsite at the South San Francisco headquarters at least four days per week; domestic and international travel of up to 10% is required.

Culture & Benefits

• Collaborative, inclusive, data-driven environment focused on precision oncology and patient outcomes.
• Medical, dental, and vision coverage, with the company paying 100% for employees and 90% for dependents.
• 401(k), employee stock purchase plan, wellness programs, and consideration for merit increases, short-term incentives, and stock options.
• Work-from-home flexibility alongside required onsite work, subject to company policy.
• Employees working in company facilities must be fully vaccinated, subject to applicable accommodations.