Product Quality Associate Director (Biologics)

Location: United States — Remote

Annual salary: $145,241.20–$196,502.80 USD

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

• Serve as the accountable Product Quality Leader for one or more late-stage or commercial biologics products.
• Represent Quality on Product Delivery Teams and define deliverables, priorities, and timelines.
• Coordinate Quality Assurance, Stability, Process Development, Quality Control, Regulatory, and other cross-functional activities.
• Lead product quality activities including annual product reviews, specifications, comparability, stability programs, site and method transfers, and quality impact assessments.
• Own, author, and review GMP and regulatory documents, filing sections, and responses to regulatory questions.
• Apply science- and risk-based evaluation to complex process and product quality data and develop patient-oriented strategies.

Requirements

• Doctorate degree plus 3 years of relevant experience; or master’s degree plus 5 years; bachelor’s degree plus 7 years; associate’s degree plus 12 years; or high school diploma/GED plus 14 years.
• Experience in Quality, Operations, Scientific, or Manufacturing functions.
• Proficiency communicating complex information to Product Quality leadership, peers, and regulatory agencies.
• Knowledge of cGMP and international regulatory expectations.
• Strong scientific data management, organization, analytical, and problem-solving skills.
• Ability to work effectively with global virtual teams, manage multiple priorities, and meet challenging timelines.

Nice to have

• B.S. or advanced degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field.
• Increasing responsibility in quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environments.
• 6+ years in a regulated environment with biologic products.
• At least 1 year of experience authoring or reviewing market applications, INDs, supplements, or similar regulatory documentation.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, vision, life, disability, and flexible spending benefits for eligible employees and dependents.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus, stock-based long-term incentives, and award-winning time-off plans.
• Career development opportunities and flexible work models where applicable.

Hiring process

• Applications are accepted until a suitable candidate is selected; there is no fixed application deadline.
• Sponsorship for this role is not guaranteed.