4 дня назад
Director GMP Compliance and Inspections (Biotech)
101 500 - 200 400$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Director GMP Compliance and Inspections (Biotech): Leading GMP compliance assessments, inspection readiness, audits, and regulatory coordination at an onsite manufacturing site in Limerick with an accent on regulatory readiness, quality systems, and continuous improvement. Focus on developing inspection-preparedness tools and metrics, coordinating responses to regulatory inspections, and strengthening compliance capabilities across operations.
Location: Limerick, Ireland; onsite Monday-Friday
Salary: 101,500.00–200,400.00 annually
Company
is a biotechnology company that develops and commercializes medicines for serious diseases.
What you will do
- Lead GMP compliance assessments and inspection-readiness initiatives across the manufacturing site.
- Monitor regulatory trends and translate them into actionable compliance improvements.
- Develop tools, processes, metrics, and content repositories for audit and inspection preparedness.
- Provide quality and regulatory guidance to internal teams and external partners.
- Coordinate regulatory inspections and internal audits, including responses and information requests.
- Partner with compliance and quality teams to identify gaps, resolve issues, and strengthen operational capabilities.
Requirements
- Bachelor’s degree in Life Sciences or a related field, or an equivalent combination of education and experience.
- Minimum 12 years of experience in a similar compliance or regulatory role.
- Experience with GMP compliance, inspections, audits, and regulatory readiness.
- Ability to work onsite in Limerick, Ireland, Monday-Friday.
Culture & Benefits
- Science-driven environment focused on developing life-transforming medicines.
- Competitive total rewards package that may include bonuses, equity awards, pension or retirement benefits, health and insurance benefits, paid time off, and family support.
- Inclusive workplace and equal opportunity employment practices.
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