Quality Assurance Manager (Biotech)

Location: Thousand Oaks, California, United States. The role supports a 24/7 facility and may require day or swing shifts with partial weekend coverage.

Company

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

What you will do

• Oversee quality assurance activities across manufacturing operations, testing, inspection, utilities, and facility processes.
• Lead the QA team through strategic direction, staff development, coaching, and performance management.
• Partner with manufacturing, supply chain, facilities, engineering, and automation teams to maintain compliant and safe operations.
• Manage deviations, change controls, CAPAs, quality records, and corrective actions to prevent recurrence.
• Prepare for and support internal and external audits, regulatory inspections, and interactions with regulatory agencies.
• Develop training programs and drive quality process optimization and continuous improvement initiatives.

Requirements

• Doctorate degree; or a master's degree with 3 years of quality experience; or a bachelor's degree with 5 years; or an associate degree with 10 years; or a high school diploma/GED with 12 years of quality experience.
• Direct people-management experience or leadership experience overseeing teams, projects, programs, or resource allocation.
• Knowledge of cGMP, FDA, EMA, and other regulatory requirements.
• Experience in quality assurance or manufacturing, preferably including 5+ years of aseptic processing and cleanroom operations.
• Strong analytical, communication, collaboration, risk-management, and operational-excellence skills.
• Availability to support different shifts, including possible weekend coverage, in a 24/7 production facility.

Nice to have

• Bachelor's degree in science.
• Experience leading regulatory audits and inspections.
• Expertise in aseptic processing, sterility, and contamination prevention.

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, stock-based long-term incentives, and paid time-off plans.
• Career development opportunities and flexible work models where applicable.