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9 дней назад

Deviation Investigation Team Manager (GMP)

Формат работы
onsite
Тип работы
fulltime
Грейд
lead
Английский
b2
Страна
UK
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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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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