GxP Quality & QMS Transformation Consultant

Consultancy.uk

Melbourn

On-site

GBP 90,000 - 130,000

Full time

3 days ago

Be an early applicant

Application generator

Turn this role into an interview — a resume and cover letter built around what this employer wants.

Get past ATS filters

Benefits offered by this job

Competitive benefits

Job summary

PA Consulting in Melbourn, United Kingdom seeks an experienced Pharma Quality Specialist Consultant to join its Life Sciences team, focusing on GxP QMS design, transformation and implementation. You will advise across pharmaceutical and biotech environments, ensuring compliance with GMP, GDP, GCP and GLP while leading quality initiatives with pragmatic consulting approaches.

You will design, validate and improve systems, write policies, and collaborate with QA, IT and business teams to deliver

Qualifications

Scientific or technical background in life sciences, quality or related discipline.
8+ years’ experience within pharmaceuticals, biotechnology or life sciences with GxP QMS transformation experience.
Strong knowledge of global GxP regulatory frameworks including FDA, EU GMP/EudraLex, MHRA, EMA and ICH guidance.
Experience drafting and managing quality documentation (SOPs, standards, policies, forms).
Hands-on supplier qualification, audits, CAPA and compliance management.

Responsibilities

Lead the design and implementation of GxP‑compliant QMS across R&D, manufacturing, clinical and distribution environments.
Lead CSV activities and develop validation strategies, protocols, test scripts and data integrity controls.
Drive supplier qualification, audits, CAPA and ongoing risk mitigation activities.
Lead regulatory information management (RIM) and PLM system implementations for end‑to‑end product data control.
Act as SME on GxP regulations and support Qualified Person (QP) responsibilities where appropriate.
Engage clients and stakeholders, translating regulatory expectations into practical process improvements.