Product Quality Director (Biotechnology)

Location: Washington, D.C., United States

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

• Serve as the Product Quality Leader for a product team and provide technical, strategic, and project leadership.
• Lead product quality activities for pivotal and commercial products, including comparability, specifications, stability, annual product reviews, and site or method transfers.
• Own product quality sections of regulatory filings, GMP documentation, change controls, data reviews, and responses to regulatory questions.
• Lead a Product Quality Team and oversee product stability programs while providing guidance to team members.
• Evaluate complex process and product quality data using science- and risk-based approaches.
• Collaborate with quality, regulatory, manufacturing, process development, analytical, and international teams on investigations, inspections, and operational improvements.

Requirements

• Doctorate degree plus 4 years of relevant experience, master's degree plus 7 years, or bachelor's degree plus 9 years in quality, operations, scientific, or manufacturing roles.
• 8+ years of pharmaceutical experience, including increasing responsibility in quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environments.
• 6+ years of direct GMP experience in a regulated environment and 5+ years managing staff with increasing responsibilities.
• Experience with large-molecule development, commercial lifecycle maintenance, protein and small-molecule quality, analytical techniques, and drug substance and drug product manufacturing.
• Experience with regulatory filings, non-conformance investigations, product quality impact assessments, project management, and cross-functional matrix teams.
• Strong leadership, communication, facilitation, presentation, and mentoring skills; knowledge of cGMP and international pharmaceutical regulations.

Nice to have

• Advanced degree in chemistry, biochemistry, biology, or a related biotechnology science.
• At least 2 years of experience as a Product Quality Leader, technical professional, or product champion.

Culture & Benefits

• Collaborative, innovative, and science-based working 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 and career development opportunities.
• Flexible work models where applicable.

Hiring process

• Applications are accepted until a sufficient number of candidates is received or a candidate is selected.
• Visa sponsorship is not guaranteed.