Product Quality Director (Hybrid Modalities)

Location: Thousand Oaks, California, United States; hybrid work model

Salary: $176,370.75–$238,619.25 annually

Company

hirify.global is a biotechnology company developing, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Lead product quality strategy and cross-functional delivery for hybrid modality programs, including ADCs.
• Oversee specifications, comparability, stability programs, site and method transfers, annual product reviews, and product quality impact assessments.
• Own product quality sections of regulatory filings, GMP documentation, system transactions, and responses to regulatory questions.
• Provide scientific and risk-based evaluation of complex processes and product quality data.
• Lead a Product Quality Team, including oversight of stability programs and indirect staff guidance.
• Mentor team members and communicate complex quality topics to leadership, peers, regulatory agencies, and inspection teams.

Requirements

• Doctorate degree with 4 years of relevant experience, master's degree with 7 years, or bachelor's degree with 9 years in quality, operations, scientific, or manufacturing work.
• Experience in pharmaceutical quality, analytical development, process development, regulatory, manufacturing, or related environments.
• Knowledge of large- and small-molecule and bioconjugate development, analytical testing, drug substance and drug product manufacturing, and industry regulations.
• At least 6 years of direct GMP experience and experience with cGMP and international regulatory expectations.
• Leadership experience managing people, teams, projects, programs, or resource allocation.
• Strong written and verbal communication, facilitation, presentation, project management, and cross-functional collaboration skills.

Nice to have

• Advanced degree in chemistry, biochemistry, biology, or a related biotechnology field.
• Experience as a technical expert or product champion.
• Experience authoring or reviewing regulatory filings and supporting non-conformance investigations.
• Experience working in a matrix environment.

Culture & Benefits

• Collaborative, innovative, science-based work environment focused on serving patients.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Annual bonus program and stock-based long-term incentives.
• Paid time off, career development opportunities, and flexible work models where applicable.
• Sponsorship is not guaranteed.