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Pharma Quality Specialist Consultant

United Kingdom, London · Job Posted May 29, 2026
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Job Description

Hybrid working - our approach is to be in the office or on client site a minimum of 2 days per week. However, the actual time you spend and where you spend it will vary by role or assignment, including up to 5 days per week on a client site. This role can be based in our London Victoria or Melbourn offices Our Life Sciences teams work with leading pharmaceutical, biotechnology and healthcare organisations to strengthen quality, compliance and operational excellence across the product lifecycle — from early research through to commercial supply. 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

  • Management Consultancy experience highly desirable
  • 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
  • Experience of RIM and PLM system implementation in regulated environments (highly desirable)
  • Knowledge of computer system validation and data integrity principles
  • Excellent problem‑solving, communication and stakeholder management skills

Nice to have

  • QP status is highly desirable but not essential
  • Experience with ISO 13485 and combination product environments would be advantageous but is not required

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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