Pharma Quality Specialist Consultant

Overview

As a Pharma Quality Specialist Consultant, you will lead GxP QMS design and transformation for life sciences clients, spanning R&D to manufacturing. You will drive compliant, scalable quality systems while collaborating with cross-functional teams to deliver tangible regulatory improvements. Your work will focus on transforming processes, validating systems, and enabling sustainable quality across global environments. This is a hands-on advisory role that combines deep regulatory expertise with pragmatic client delivery.

Pay / Benefits

• private healthcare
• 25 days annual leave (+1/2 day on Christmas Eve)
• generous pension
• annual performance-based bonus
• PA share ownership
• cycle to work/y tax benefits

Responsibilities

• Design and implement GxP-compliant QMS across R&D, manufacturing, clinical and distribution environments
• Conduct process mapping, gap assessments and support rollout of new/enhanced systems aligned to GMP, GDP, GCP, GLP and related standards
• Author, review and maintain quality policies, SOPs, forms and documentation to sustain compliance
• Lead CSV activities and develop validation strategies, protocols and data integrity controls
• Support supplier qualification, audits, CAPA, and risk mitigation initiatives
• Lead/regulatory systems implementations (RIM) to improve submission tracking and data integrity
• Support PLM implementations for end-to-end product data control across development phases
• Act as SME on GxP regulations and provide inspection readiness and QP support where appropriate
• Engage with clients and stakeholders to translate regulatory expectations into practical improvements
• Facilitate cross-functional collaboration to deliver QMS and regulatory initiatives

Key requirements

• 8+ years within pharmaceuticals, biotechnology or life sciences with strong GxP QMS transformation and implementation track record
• Scientific or technical background in life sciences, pharmaceutical sciences, quality or related discipline
• Extensive experience drafting and managing quality documentation (SOPs, standards, policies, forms)
• Strong knowledge of global GxP regulatory frameworks (FDA, EU GMP/EudraLex, MHRA, EMA, ICH)
• Hands-on experience with supplier qualification, audits, CAPA and compliance management
• Experience with RIM and PLM system implementations (highly desirable)
• Knowledge of CSV and data integrity principles
• Excellent problem-solving, communication and stakeholder management skills
• QP status is highly desirable but not essential
• ISO 13485 and combination product experience advantageous but not required

• problem-solving
• communication
• stakeholder management
• GxP QMS design and transformation
• GMP/GDP/GCP/GLP regulatory knowledge
• CSV

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