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QA Specialist V - Quality Risk Management (QRM)

Формат работы
onsite
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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Мэтч & Сопровод

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Описание вакансии

Текст:
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TL;DR
QA Specialist V - Quality Risk Management (QRM) (GMP/Quality Risk Management): Leading cross-functional quality risk assessments and maintaining a site-wide risk management framework with an accent on risk-based decision-making, regulatory compliance, and continuous improvement. Focus on facilitating risk assessments, improving risk registers and governance processes, delivering QRM training, and supporting audits and inspections.

Location: Portsmouth, New Hampshire, USA

Company

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

What you will do

  • Lead cross-functional quality risk assessments and facilitate risk-based decision-making.
  • Provide Quality Risk Management expertise for site projects and initiatives.
  • Maintain and improve site risk registers and governance processes.
  • Develop, deliver, and continuously improve QRM training programs.
  • Support audits, inspections, and regulatory readiness activities.
  • Review risk assessments for compliance with site procedures and drive continuous improvement.

Requirements

  • Bachelor's degree in Life Sciences or a related field.
  • Experience working in a GMP-regulated environment.
  • Knowledge of Quality Risk Management principles and risk assessment methodologies.
  • Strong analytical, problem-solving, decision-making, communication, and facilitation skills.
  • Ability to manage multiple priorities and deliver results independently.
  • Strong collaboration and stakeholder management capabilities.

Culture & Benefits

  • Full-time position in a dynamic and collaborative working culture.
  • Opportunity to influence site-wide quality and risk management strategies.
  • Exposure to cross-functional teams and senior stakeholders.
  • Professional growth and ongoing development opportunities.
  • Medical, dental, and vision insurance.
  • Inclusive and ethical workplace with compensation programs that recognize high performance.

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