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3 часа назад

Associate Director, Quality Assurance (Pharmaceutical Manufacturing)

Формат работы
onsite
Тип работы
fulltime
Грейд
director
Английский
b2
Страна
US
Релокация
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
Associate Director, Quality Assurance (Pharmaceutical Manufacturing): Leading the Bend site's quality assurance management system and critical quality programs with an accent on GMP compliance, investigations, change controls, CAPAs, and regulatory readiness. Focus on developing high-performing quality teams, supporting FDA and client audits, and driving risk-based quality strategies in pharmaceutical manufacturing.

Location: Fully site-based in Bend, Oregon, United States. Relocation assistance is available for eligible candidates and their families.

Company

hirify.global is a global life sciences company with more than 30 sites across five continents, manufacturing medicines and supporting the development of therapies.

What you will do

  • Lead and oversee the site's Quality Assurance Management System to ensure regulatory and corporate compliance.
  • Serve as the primary Quality Assurance contact for site quality systems and quality-related activities.
  • Oversee investigations, change controls, and CAPA programs for timely and compliant execution.
  • Lead, coach, and develop Quality Assurance team members.
  • Support client and regulatory audits and maintain an inspection-ready environment.
  • Partner with clients, project teams, and site stakeholders on risk-based quality strategies and continuous improvement.

Requirements

  • Bachelor's degree in engineering, life sciences, or a related field.
  • 10+ years of Quality Assurance experience in the pharmaceutical, biotechnology, or related industry.
  • Experience leading quality teams and developing high-performing employees.
  • Strong knowledge of GMP regulations and pharmaceutical manufacturing operations.
  • Experience with FDA regulations, including CFR Parts 11, 210, 211, and 820.
  • Proven ability to manage quality systems, investigations, change controls, and CAPA programs, with strong communication, collaboration, and problem-solving skills.

Culture & Benefits

  • Agile career development and a dynamic working culture.
  • Inclusive and ethical workplace.
  • Medical, dental, and vision insurance.
  • Performance-focused compensation programs and comprehensive benefits.
  • Opportunities to lead quality professionals and participate in cross-functional and global quality initiatives.

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