Product Quality Director (Biotech)

Location: United States - Remote

Annual salary: USD 176,370.75–238,619.25

Company

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

What you will do

• Lead product quality strategy and provide scientific, technical, and project leadership for late-phase and commercial product programs.
• Direct activities covering specifications, comparability, stability, annual product reviews, site and method transfers, investigations, change control, and non-conformance impact assessments.
• Lead a Product Quality Team and oversee product stability programs, GMP documentation, regulatory filing sections, and quality system transactions.
• Provide risk-based evaluation of complex process and product quality data and develop patient-oriented strategies for complex quality issues.
• Communicate technical information to leadership, cross-functional partners, and regulatory agencies, including during inspections.
• Mentor Product Quality staff and support operationally efficient processes across international sites.

Requirements

• Doctorate degree plus 4 years, master’s degree plus 7 years, or bachelor’s degree plus 9 years of relevant Quality, Operations, Scientific, or Manufacturing experience.
• Experience in pharmaceutical quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environments.
• Knowledge of protein and small-molecule quality, analytical techniques, drug substance and drug product development, manufacturing, and industry regulations.
• Direct experience in regulated environments and working knowledge of cGMP and international regulatory expectations.
• Experience leading staff, managing cross-functional work in a matrix environment, and supporting product development projects.
• Strong written and verbal communication, facilitation, presentation, leadership, and management skills.

Nice to have

• Advanced degree in chemistry, biochemistry, biology, or a related biotechnology field.
• Experience as a Product Quality Leader, technical professional, or product champion.
• Experience authoring or reviewing regulatory filings and defending critical product-impacting non-conformances.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• 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, work-life balance support, and career development opportunities.