4 дня назад
GCP Quality Auditor
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
GCP Quality Auditor (Clinical Research Compliance): Planning, conducting, and reporting international GCP compliance audits across clinical trial activities with an accent on regulatory inspection support, risk identification, and quality process improvement. Focus on leading complex audits, developing controlled quality documents, and assessing compliance across global clinical development and post-marketing activities.
Location: United Kingdom — remote with regular office work from Cambridge or Uxbridge; up to 40% international travel.
Company
is a biotechnology company researching, manufacturing, and delivering treatments for patients worldwide.
What you will do
- Plan, conduct, and report routine and directed GCP compliance audits internationally.
- Lead complex GCP audits and communicate compliance risks to R&D Quality management.
- Support and participate in regulatory authority inspections of clinical sites and company facilities.
- Contribute to R&D Quality process improvement initiatives.
- Author and support the development of cross-functional controlled quality documents.
Requirements
- Degree-level education.
- Proven and extensive international auditing experience in GCP.
- Excellent written and verbal communication skills.
- Ability to work from the United Kingdom with regular office attendance in Cambridge or Uxbridge.
- Willingness and ability to travel internationally, potentially up to 40% of the time.
Nice to have
- Experience with data mining, data manipulation, and data analytics.
Culture & Benefits
- Opportunities for learning and career mobility across a global organization.
- Diverse and inclusive working environment where employees are encouraged to contribute ideas and take action.
- Total rewards package covering health, financial security, work-life balance, and career benefits.
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