Pharma Quality Specialist Consultant

Overview

In this role you will drive GxP quality management system (QMS) design, transformation and implementation for life sciences clients. You will partner with cross-functional teams to embed compliant, scalable processes across R&D, manufacturing and distribution, supporting regulatory readiness. Your work focuses on translating complex regulations into practical improvements that enhance quality and operational excellence. You will join a collaborative Life Sciences practice that helps clients navigate GMP, GDP, GCP and GLP requirements at pace. This is an opportunity to shape quality programs for leading pharmaceutical and biotech organizations.

Pay / Benefits

• private healthcare
• 25 days annual leave plus Christmas Eve half day
• generous pension
• annual performance-based bonus
• PA share ownership
• cycle to work program

Responsibilities

• Design and implement GxP-compliant QMS across R&D, manufacturing, clinical and distribution environments
• Conduct process mapping, gap assessments and rollout of enhanced systems aligned to regulatory standards
• Author and maintain quality policies, standards, SOPs, forms and controlled docs
• Lead computer system validation initiatives and develop validation strategies and test scripts
• Support supplier qualification, audits, CAPA and risk mitigation activities
• Lead Regulatory Information Management (RIM) and Product Lifecycle Management (PLM) system implementations
• Act as SME on GxP regulations and inspection readiness; support Qualified Person (QP) responsibilities
• Engage with clients and stakeholders to translate complex regulatory expectations into practical improvements
• Foster cross-functional collaboration to deliver successful QMS and regulatory initiatives

Key requirements

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

• problem-solving
• clear communication
• stakeholder management
• GxP QMS design and transformation
• GMP/GDP/GCP/GLP knowledge
• Regulatory Information Management (RIM) systems

…