6 дней назад
QA Manager, Deviations (Biotechnology)
75 915 - 102 708€
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
QA Manager, Deviations (GMP/Quality Systems): Leading quality professionals and overseeing manufacturing deviations, investigations, CAPAs, change controls, and quality assessments with an accent on GMP compliance, regulatory readiness, and risk-based decision-making. Focus on leading inspections and audits, managing cross-functional quality issues, and driving continuous improvement across pharmaceutical manufacturing operations.
Location: Dublin, Ireland
Salary: €75,915.20–€102,708.80 per year
Company
is a biotechnology and pharmaceutical organization operating in a regulated manufacturing environment.
What you will do
- Lead and develop a team of Quality professionals through recruitment, training, and performance development.
- Provide strategic and operational leadership for manufacturing deviations in accordance with cGMP, GDP, internal standards, and regulatory requirements.
- Oversee deviations, investigations, CAPAs, change controls, and related quality assessments within the Quality Management System.
- Make risk-based decisions on complex quality, compliance, and operational issues, escalating significant risks when required.
- Partner with Manufacturing, Engineering, Validation, Quality Control, Supply Chain, and other functions to support reliable operations.
- Lead inspection readiness, audits, governance activities, remediation commitments, and continuous improvement initiatives.
Requirements
- Degree in Science, Engineering, Pharmacy, or a related discipline.
- 7+ years of experience in the pharmaceutical or biotechnology industry with increasing responsibility.
- Leadership experience managing teams, developing talent, and improving performance.
- Strong expertise in GMP quality systems, deviations, investigations, CAPA management, change controls, and risk management.
- Experience supporting regulatory inspections and leading audit readiness activities.
- Strong communication, stakeholder management, facilitation, decision-making, analytical, and problem-solving skills in a matrix environment.
Culture & Benefits
- Focus on safety, quality, accountability, inclusion, compliance, and continuous improvement.
- Opportunity to support site and global quality strategies through simplification, standardization, and process optimization.
- Responsibility for promoting environmental, health, safety, and sustainability requirements.
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