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3 дня назад

Senior Manager QA Auditor (GCP Strategy)

86 800 - 141 200$
Формат работы
remote (только Europe)
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
UK/US/Ireland
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 Manager QA Auditor (GCP Strategy) (Global Development Quality Assurance): Leading risk-based GCP audit planning and compliance programs across therapeutic areas and studies with an accent on regulatory alignment, audit outcomes, and cross-functional quality oversight. Focus on identifying risk trends, supporting regulatory inspections, and delivering strategic reports and metrics to senior leadership.

Location: Remote in the UK or Ireland; 10–20% travel may be required.

Salary: $86,800–$141,200 annually.

Company

hirify.global is a science-driven biotechnology company developing medicines for people with serious diseases.

What you will do

  • Lead risk-based audit planning across therapeutic areas and clinical studies.
  • Drive strategic audit programs using risk indicators from study teams.
  • Ensure audits align with approved programs and scheduled timelines.
  • Manage audit outcomes, identify trends, and communicate quality risks.
  • Represent quality assurance in complex cross-functional initiatives.
  • Deliver audit reports and metrics to Global Development leadership.

Requirements

  • Bachelor’s degree and 8+ years of relevant industry experience.
  • 5+ years of GCP audit strategy or audit experience.
  • Knowledge of FDA, EU, and ICH GCP regulations and guidance.
  • Experience supporting or participating in regulatory inspections.
  • Strong project management and stakeholder management capabilities.
  • Excellent written and verbal communication skills with senior audiences.

Culture & Benefits

  • Remote work arrangement for the UK or Ireland.
  • Inclusive workplace with reasonable accommodations available during recruitment where required.
  • Potential benefits include bonuses, equity awards, pension or retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits.
  • Background checks may verify identity, right to work, and educational qualifications in accordance with local law.

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