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About the Role

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. 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.

Responsibilities

Lead the design and implementation of GxP-compliant QMS across R&D, manufacturing, clinical and distribution environments.
Conduct process mapping and gap assessments, and support the rollout of new or enhanced systems aligned to global regulatory standards (including GMP, GDP, GCP, GLP, FDA 21 CFR 210/211, EU GMP/EudraLex, ICH Q7/Q10).
Author, review and maintain quality policies, standards, SOPs, forms and controlled documentation, enabling sustainable compliance and operational excellence.
Support effective change management, embedding best practices through close collaboration with quality, technical and business teams.
Lead and advise on computer system validation (CSV) activities within GxP environments.
Support the development of validation strategies, protocols, test scripts and data integrity controls in line with global regulatory expectations.
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 ongoing risk mitigation activities.
Lead the implementation and optimisation of Regulatory Information Management (RIM) systems to improve submission tracking, data integrity and global regulatory oversight.
Support Product Lifecycle Management (PLM) system implementations to enable end-to-end control of product data, changes and documentation across development phases.
Work closely with client IT, regulatory and quality teams to tailor solutions that are practical, scalable and compliant.
Act as a subject matter expert on GxP regulations and inspection readiness.
Act as, or support, a Qualified Person (QP) for product certification and release, where appropriate.
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.

Requirements

Management Consultancy experience highly desirable
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.
Must meet residency requirements for UK security clearance (British citizen or resident in the UK for the past 5 years).

Skills

GxP Quality Management System (QMS) design, transformation and implementation
GMP, GDP, GCP and GLP compliance
Process mapping
Gap assessments
Quality policies, standards, SOPs, forms and controlled documentation
Change management
Computer system validation (CSV)
Data integrity
Supplier qualification, evaluation and audit
CAPA development
Risk mitigation
Regulatory Information Management (RIM) systems implementation
Product Lifecycle Management (PLM) system implementation
Regulatory and Qualified Person (QP) support
Inspection readiness
Stakeholder management

Location

London Victoria office
Melbourn office

Work Type

Hybrid working
Minimum 2 days per week in office or on client site
Up to 5 days per week on client site possible

Experience Level

8+ years experience within pharmaceuticals, biotechnology or life sciences

Education Level

Scientific or technical background (life sciences, pharmaceutical sciences, quality or a related discipline)

Benefits

Health and lifestyle perks accompanying private healthcare
25 days annual leave (plus a bonus half day on Christmas Eve)
Opportunity to buy 5 additional days annual leave
Generous company pension scheme
Opportunity to get involved with community and charity-based initiatives
Annual performance-based bonus
PA share ownership
Tax efficient benefits (cycle to work, give as you earn)

About the Company

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

Equal Opportunity

We are dedicated to supporting the physical, emotional, social and financial well-being of our people.
We're focused on building a workplace that values human difference and diverse mindsets, and a culture of inclusion and equality that unlocks the potential in our people so everyone can be their best self.
We’re 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 underrepresented groups.
Should you need any adjustments or accommodations to the recruitment process, at either application or interview, please contact us on [email protected]