Pharma Quality Specialist Consultant

Pa Consulting; Greater London, Melbourn; Hybrid; GBP 85,000 - 130,000; Full time

Job summary

PA Consulting is seeking an experienced Pharma Quality Specialist Consultant to join the Life Sciences team. You will design and implement GxP-compliant QMS across R&D, manufacturing, and distribution, aligning with GMP, GDP, GCP, GLP standards.

You will lead CSV activities, support RIM/PLM implementations, and provide QP support where appropriate, while engaging with clients to deliver practical, compliant solutions.

Qualifications

• Minimum 8+ years in pharma/biotech with GxP QMS transformation experience.
• Experience drafting and managing quality documentation (SOPs, standards, policies).
• Strong knowledge of global GxP regulatory frameworks (FDA, EU GMP/EudraLex, MHRA, EMA, ICH).

Responsibilities

• Design and implement GxP-compliant QMS across R&D, manufacturing, clinical and distribution environments.
• Lead CSV activities and develop validation strategies, protocols and data integrity controls.
• Coach supplier qualification, audits, CAPA and risk mitigation.
• Lead regulatory information management (RIM) and PLM system implementations.
• Act as SME on GxP regulations and inspection readiness; support Qualified Person (QP) for product certification where applicable.
• Engage clients and stakeholders; translate regulatory expectations into practical process improvements.

Skills

Quality management

Regulatory knowledge

Stakeholder management

Process transformation

GxP compliance

Education

Scientific/technical background

Tools

RIM

PLM

CSV

Job description

Job Description

• 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/EudraLex, 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 solutions that are practical, scalable and compliant.

Regulatory and Qualified Person (QP) support

• Acting as a subject matter expert on GxP regulations and inspection readiness.
• Acting as, or supporting, a Qualified Person (QP) for product certification and release, where appropriate.

Client and stakeholder engagement

• Building trusted relationships with clients, quality leaders, business stakeholders and regulators.
• Translating complex regulatory expectations into clear, practical process improvements.
• Leading and facilitating cross-functional collaboration to deliver successful QMS and regulatory initiatives.

Qualifications

• 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.

We are dedicated to supporting the physical, emotional, social and financial well-being of our people. Check out some of our extensive benefits:

Life At PA encompasses our peoples' experience at PA. It's about how we enrich peoples' working lives by giving them access to unique people and growth opportunities and purpose led meaningful work.

Our purpose guides how we work with our clients and our teams, and support our communities, to deliver insight and impact, solving the world's most complex challenges. 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.

Find out more about Life at PA here.