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Pharma Quality Specialist Consultant

United Kingdom, Melbourn · Job Posted April 24, 2026
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Job Description

We are seeking an experienced Pharma Quality Specialist Consultant to join our Life Sciences consulting team, specialising in GxP Quality Management System (QMS) design, transformation and implementation. In this role, you will advise clients across pharmaceutical, biotechnology and related life sciences environments, supporting compliance with GMP, GDP, GCP and GLP requirements. You will lead and deliver quality transformation initiatives, combining strong hands‑on expertise with a pragmatic, client‑focused consulting approach.

Job Responsibility

  • QMS design and process transformation
  • Computer system validation and data integrity
  • Supplier quality and audit support
  • Regulatory systems implementation
  • Regulatory and Qualified Person (QP) support
  • Client and stakeholder engagement

Requirements

  • A scientific or technical background (life sciences, pharmaceutical sciences, quality or a related discipline)
  • Typically 8+ years’ experience within pharmaceuticals, biotechnology or life sciences, with a strong track record in GxP QMS transformation and implementation
  • Extensive experience drafting and managing quality documentation, including SOPs, standards, policies, forms and templates
  • Strong knowledge of global GxP regulatory frameworks, including FDA, EU GMP/EudraLex, MHRA, EMA and ICH guidance
  • Hands‑on experience with supplier qualification, audits, CAPA and compliance management
  • Excellent problem‑solving, communication and stakeholder management skills

Nice to have

  • Management Consultancy experience
  • Experience of RIM and PLM system implementation in regulated environments
  • QP status
  • Experience with ISO 13485 and combination product environments

What we offer

  • Health and lifestyle perks accompanying private healthcare
  • 25 days annual leave (plus a bonus half day on Christmas Eve) with the opportunity to buy 5 additional days
  • Generous company pension scheme
  • Opportunity to get involved with community and charity-based initiatives
  • Annual performance-based bonus
  • PA share ownership
  • Tax efficient benefits (cycle to work, give as you earn)

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