обновлено 11 дней назад
QA Specialist V - Quality Risk Management (QRM)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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
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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