Pharma Quality Specialist Consultant

We believe in the power of ingenuity to build a positive human future.

As strategies, technologies, and innovation collide, we create opportunity from complexity.

Our teams of interdisciplinary experts combine innovative thinking and breakthrough technologies to progress further, faster. Our clients adapt and transform, and together we achieve enduring results.

We are over 4,000 strategists, innovators, designers, consultants, digital experts, scientists, engineers, and technologists. And we have deep expertise in consumer and manufacturing, defence and security, energy and utilities, financial services, government and public services, health and life sciences, and transport.

Our teams operate globally from offices across the UK, Ireland, US, Nordics, and Netherlands.

PA. Bringing Ingenuity to Life.

• 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.

What you’ll do

You’ll work across a diverse portfolio of client engagements, applying your quality expertise to deliver tangible impact. Your work will include:

QMS design and process transformation

• Leading the design and implementation of GxP‑compliant QMS across R&D, manufacturing, clinical and distribution environments.
• Conducting process mapping and gap assessments
  , and supporting the 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).
• Authoring, reviewing and maintaining quality policies, standards, SOPs, forms and controlled documentation
  , enabling sustainable compliance and operational excellence.
• Supporting effective change management
  , embedding best practices through close collaboration with quality, technical and business teams.

Computer system validation and data integrity

• Leading and advising on computer system validation (CSV) activities within GxP environments.
• Supporting the development of validation strategies, protocols, test scripts and data integrity controls in line with global regulatory expectations.

Supplier quality and audit support

• Applying hands‑on experience in supplier qualification, evaluation and audit activities (internal and external).
• Interpreting audit findings and supporting CAPA development
  , supplier improvement initiatives and ongoing risk mitigation activities.

Regulatory systems implementation

• Leading the implementation and optimisation of Regulatory Information Management (RIM) systems to improve submission tracking, data integrity and global regulatory oversight.
• Supporting Product Lifecycle Management (PLM) system implementations to enable end‑to‑end control of product data, changes and documentation across development phases.
• Working closely with client IT, regulatory and quality teams to tailor…