QA Manager - Nights (Biotechnology)

Location: West Greenwich, Rhode Island, United States; onsite night shift, Monday–Friday, 6:00 p.m.–2:30 a.m.

Salary: USD 118,235–159,965 annually

Company

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

What you will do

• Hire, train, develop, and manage Quality Assurance professionals supporting GMP manufacturing.
• Oversee night-shift QA operations, communicate goals, and manage performance improvement initiatives.
• Develop and interpret procedures, standards, manufacturing procedures, and quality controls.
• Review and approve operational and manufacturing procedures, validation protocols and reports, environmental characterization reports, and change controls.
• Approve non-conformances and change-over completion controls while representing QA on project and incident triage teams.
• Lead investigations, plant and site audits, and cross-functional efforts to resolve issues and drive compliant change.

Requirements

• High school diploma/GED with 12 years of Quality or Manufacturing experience; or an associate degree with 10 years; or a bachelor’s degree with 5 years; or a master’s degree with 3 years; or a doctorate degree.
• Direct people-management or team, project, program, or resource-allocation leadership experience.
• Experience in quality assurance or manufacturing, preferably within the biotechnology or pharmaceutical industry.
• Experience with manufacturing, investigations, CAPA, product release, validation, or change control.
• Knowledge of regulations and standards for biotech manufacturing in a multi-product environment.
• Ability to make independent risk-based decisions, communicate clearly, coach staff, and influence compliant manufacturing practices.

Nice to have

• Bachelor’s degree in Life Sciences, Engineering, or a related field.
• 6+ years of quality assurance or combined quality and manufacturing experience in biotechnology or pharmaceuticals.
• 2+ years of supervisory or management experience.
• Knowledge of monoclonal antibody manufacturing.

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 plans and career development opportunities.