Pharma Quality Specialist Consultant

Job Overview

We are seeking an experienced Pharma Quality Specialist Consultant to join our Life Sciences consulting team, specializing in GxP Quality Management System (QMS) design, transformation and implementation
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Hybrid working is the norm: a minimum of two days per week in the office or on client site, with flexibility up to five days on a client site. The role may be based in London Victoria or Melbourn.

• Lead the design and implementation of GxP‑compliant QMS across R&D, manufacturing, clinical and distribution environments.
• Conduct process mapping and gap assessments, supporting rollout of new or enhanced systems aligned to global regulatory standards (including GMP, GDP, GCP, GLP, FDA 21 CFR 210/211, EU GMP/Eudra Lex, ICH Q7/Q10).
• Author, review and maintain quality policies, standards, SOPs, forms and controlled documentation to enable sustainable compliance.
• Support effective change management, embedding best practices through collaboration with quality, technical and business teams.
• Lead and advise on computer system validation (CSV) activities within GxP environments, supporting development of validation strategies, protocols, test scripts and data integrity controls.
• Apply hands‑on experience in supplier qualification, evaluation and audit activities (internal and external); interpret audit findings and support CAPA development, supplier improvement initiatives and risk mitigation.
• Lead the implementation and optimisation of Regulatory Information Management (RIM) systems to improve submission tracking and global regulatory oversight; support Product Lifecycle Management (PLM) system implementations to enable end‑to‑end control of product data.
• Act as a subject‑matter expert on GxP regulations and inspection readiness; where appropriate act as or support a Qualified Person (QP) for product certification and release.
• Build trusted relationships with clients, quality leaders, business stakeholders and regulators; translate complex regulatory expectations into clear, practical process improvements.
• Lead and facilitate cross‑functional collaboration to deliver successful QMS and regulatory initiatives.

• Management consultancy experience is highly desirable.
• Scientific or technical background in life sciences, pharmaceutical sciences, quality or a related discipline.
• 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 (SOPs, standards, policies, forms and templates).
• Strong knowledge of global GxP regulatory frameworks (FDA, EU GMP/Eudra Lex, MHRA, EMA, ICH).
• Hands‑on experience with supplier qualification, audits, CAPA and compliance management.
• Experience with RIM and PLM system implementation in regulated environments is 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 is advantageous but not required.

We are committed to advancing equality. We recruit, retain, reward and develop our people based solely on their abilities and contributions and without reference to their age, background, disability, genetic information, parental or family status, religion or belief, race, ethnicity, nationality, sex, sexual orientation, gender identity (or expression), political belief, veteran status, or any other range of human difference brought about by identity and experience.

We welcome applications from under‑represented groups.

• Health and lifestyle perks with 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.
• Annual performance‑based bonus.
• PA share ownership.
• Tax‑efficient benefits (cycle to work, give as you earn).