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1 день назад

Quality Systems And Compliance

152 000 - 190 000$
Формат работы
remote (только USA)/hybrid
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
Quality Systems And Compliance (GxP/Clinical Development): Designing and implementing a Quality Management System for clinical development programs and a growing drug pipeline with an accent on regulatory compliance, inspection readiness, and scalable quality operations. Focus on managing CAPA, deviations, investigations, change controls, risk assessments, eQMS, and internal and third-party audits across U.S. and global clinical programs.

Location: Remote in the United States or hybrid at the San Diego headquarters

Compensation: $152,000–$190,000 per year

Company

hirify.global is a clinical-stage life-science and technology company developing medicines through an AI-driven discovery and development platform.

What you will do

  • Execute and support the ongoing effectiveness of the Quality Management System.
  • Manage deviations, investigations, CAPA, change controls, risk assessments, quality events, and effectiveness checks with internal teams and external partners.
  • Create controlled documents and governance frameworks for core quality processes and continuous improvement.
  • Translate regulatory and quality requirements into practical, scalable operating models.
  • Monitor compliance risks through data-driven quality oversight and coordinate internal and third-party audits.
  • Prepare U.S.-based and global clinical programs for regulatory inspections through quality systems and cross-functional alignment.

Requirements

  • Bachelor’s degree in a scientific or technical field such as biology, chemistry, engineering, or health science.
  • 6+ years of progressive Quality experience in a GxP-regulated industry.
  • Experience implementing or improving a Quality Management System and maintaining electronic QMS platforms such as Veeva, ZenQMS, or MasterControl.
  • Experience supporting inspection readiness, audits, or regulatory interactions.
  • Working knowledge of GCP and applicable GMP principles, global regulatory expectations, risk-based quality systems, and continuous improvement.
  • Experience leading cross-functional collaboration with Regulatory, CMC, Clinical Operations, Information Technology, and R&D teams.

Culture & Benefits

  • Inclusive environment focused on collaboration across diverse backgrounds and disciplines.
  • Company-paid healthcare and flexible spending accounts.
  • Voluntary life insurance and 401(k) matching.
  • Uncapped vacation.
  • Access to an onsite gym and dining at the San Diego facility.

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