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1 день назад

Senior GMP Quality Assurance Manager

150 000 - 194 700$
Формат работы
remote (только USA)
Тип работы
fulltime
Грейд
senior
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
Senior GMP Quality Assurance Manager (Biotech): Managing GMP quality oversight for external manufacturing, testing, and supply chain activities with an accent on batch records, deviations, CAPAs, change controls, audits, and quality agreements. Focus on assessing quality risk across CMO/CDMO partners, supporting health authority inspections, and ensuring compliance with GMP regulations and company quality standards.

Location: Remote, with periodic travel to hirify.global offices for in-person collaboration and business operations

Salary: $150,000–$194,700 USD per year, plus potential discretionary annual bonus and long-term incentive award.

Company

hirify.global is a clinical-stage biotechnology company developing precision therapies for autoimmune and inflammatory diseases.

What you will do

  • Provide GMP quality oversight of manufacturing, testing, and supply chain activities.
  • Review and approve batch records, deviations, CAPAs, and product-quality change controls.
  • Oversee CMO/CDMO manufacturing and testing activities and manage quality risks across external partners.
  • Lead or support internal and external GMP audits and manage quality agreements.
  • Represent Quality during health authority inspections.

Requirements

  • Strong technical expertise in GMP quality assurance.
  • Experience overseeing external manufacturing, testing, and supply chain activities.
  • Ability to assess and manage quality risk across CMO/CDMO partners.
  • Sound judgment in applying GMP regulations and company quality standards.
  • Ability to travel periodically to company offices for in-person collaboration and business operations.

Culture & Benefits

  • Remote work arrangement with periodic in-person office visits.
  • Comprehensive benefits package tailored to the country or region of hire.
  • Potential discretionary annual bonus and long-term incentive award, such as equity.
  • Benefits and compensation are subject to local laws, eligibility requirements, and plan terms.

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