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