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12 часов назад

Quality Assurance Manager (Biotech)

118 235 - 159 965$
Формат работы
onsite
Тип работы
fulltime
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Quality Assurance Manager (Biotech): Overseeing quality assurance operations for a 24/7 biopharmaceutical manufacturing facility with an accent on cGMP compliance, aseptic processing, audits, and quality systems. Focus on leading QA teams, managing deviations, change controls, and CAPAs, and driving continuous improvement across manufacturing and cross-functional operations.

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

Annual salary: $118,235–$159,965.

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

  • Oversee daily QA operations and provide quality oversight for manufacturing, testing, inspection, utilities, and facility activities.
  • Lead the QA team through strategic direction, staff development, coaching, and performance management.
  • Maintain compliance with cGMP practices and FDA, EMA, and other regulatory requirements.
  • Coordinate internal and external audits and inspections, including direct interaction with regulatory agencies during on-site inspections.
  • Manage deviations, change controls, CAPAs, quality records, and quality-related issues to prevent recurrence.
  • Drive process optimization, continuous improvement projects, and quality oversight for manufacturing initiatives.

Requirements

  • Doctorate degree; or a master’s degree with 3 years of quality experience; or a bachelor’s degree with 5 years of quality experience; or an associate’s degree with 10 years of quality experience; or a high school diploma/GED with 12 years of quality experience.
  • Direct people-management experience or leadership experience for teams, projects, programs, or resource allocation.
  • Experience supporting manufacturing operations, quality systems, audits, inspections, and regulatory compliance.
  • Strong leadership, analytical, communication, collaboration, risk-management, and problem-solving skills.
  • Ability to work shifts within a 24/7 facility schedule, including possible partial weekend coverage.

Nice to have

  • Bachelor’s degree in science.
  • More than 5 years of aseptic processing experience in QA or manufacturing.
  • Expertise in aseptic processing and cleanroom operations.
  • Experience leading regulatory audits and inspections.

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

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