14 дней назад
Senior Manager, Corporate Audit (GCP)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Manager, Corporate Audit (GCP): Planning and leading independent Good Clinical Practice audits and risk oversight activities across clinical development with an accent on regulatory compliance, control effectiveness, and data-driven risk assessment. Focus on analyzing complex data, adapting audit methodologies, communicating findings to senior management, and developing practical recommendations for risk mitigation.
Location: Ireland – Dublin – Ringsend; legally eligible to work in Ireland and the EU
Company
is a pharmaceutical company focused on developing medicines and improving patient health through clinical research, digital transformation, and data-driven solutions.
What you will do
- Plan, lead, and conduct independent Good Clinical Practice audits and related oversight activities.
- Assess audit risks, controls, compliance with GCP regulations, internal policies, and industry standards.
- Develop customized audit plans, including data analytics and controls testing where appropriate.
- Analyze large data sets to identify risks and discrepancies and communicate findings to senior management.
- Prepare formal audit reports with practical recommendations for corrective and preventive actions.
- Support compliance investigations, assessments, process improvements, and special projects.
Requirements
- Bachelor’s degree in biology, chemistry, nursing, medical technology, pharmacy, health, or a related field; an advanced degree is preferred.
- 10 or more years of relevant international GCP operational experience in clinical development.
- At least 5 years of experience in GCP quality-related compliance.
- Extensive knowledge of ICH GCP and applicable global and local clinical development regulations.
- Strong analytical, strategic thinking, project management, leadership, communication, presentation, negotiation, and influencing skills.
- Must be legally eligible to work in Ireland and the EU; no relocation support is available.
Nice to have
- Previous experience in GCP risk assessment or analysis.
- Experience with complex business models involving outsourcing and partnerships.
- Advanced degree in a relevant scientific or healthcare field.
Culture & Benefits
- Work within a patient-centric organization guided by courage, joy, equity, and excellence.
- Contribute to digital transformation involving data, modeling, and automation in drug discovery and development.
- Collaborate with stakeholders across corporate audit, business functions, and management levels.
- Travel domestically and internationally up to 30%.
- supports an inclusive workplace and reasonable adjustments for candidates with disabilities.
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