9 дней назад
Deviation Investigation Team Manager (GMP)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Deviation Investigation Team Manager (GMP): Leading deviation investigations for biopharmaceutical process development and small-scale GMP manufacturing with an accent on root cause analysis, product impact assessment, CAPA implementation, and compliance. Focus on managing Technical Investigators, resolving complex quality events, aligning cross-functional stakeholders, and supporting timely batch disposition and customer delivery.
Location: Fully site-based in Slough, UK
Company
Biopharmaceutical process development and small-scale GMP manufacturing across a globally connected life-sciences organization.
What you will do
- Lead and develop the Deviation Investigation Team, including training, coaching, and competency development for Technical Investigators.
- Oversee manufacturing and technical-service deviation investigations through root cause analysis, product impact assessment, effective CAPA implementation, and timely closure.
- Apply risk-based quality event management and escalate issues affecting product quality, compliance, or customer delivery.
- Partner with Manufacturing, MSAT, QA, QC, QP, and Project Management stakeholders to resolve investigations and support batch disposition.
- Lead customer communications, investigation meetings, and stakeholder updates for deviation events.
- Drive continuous improvement, monitor investigation metrics, and maintain inspection and audit readiness.
Requirements
- BSc in a relevant scientific or engineering discipline, or equivalent experience.
- Experience in biotechnology, pharmaceuticals, or GMP manufacturing, with a strong understanding of quality systems and compliance requirements.
- Expertise in deviation investigations, root cause analysis, risk management, FMEA, and corrective and preventive actions.
- Strong communication, stakeholder management, technical writing, and problem-solving skills.
- Experience authoring and reviewing GMP deviations, investigations, technical reports, and quality documentation.
- Experience supporting regulatory inspections and customer audits, including presenting investigation outcomes as a quality and compliance subject matter expert.
Culture & Benefits
- Agile career development and a dynamic working culture.
- Inclusive and ethical workplace.
- Performance-focused compensation programs.
- Benefits vary according to role and location.
- In-person collaboration supports technical precision and quality in medicines manufacturing.
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