GxP Quality Transformation Consultant

Consultancy.uk; Greater London; Hybrid; GBP 90,000 - 140,000; Full time

Benefits offered by this job

Health and lifestyle perks

25 days annual leave

Pension scheme

Bonus

PA share ownership

Job summary

PA Consulting in London seeks an experienced Pharma Quality Specialist Consultant to join its Life Sciences team, focusing on GxP QMS design, transformation and implementation. You will advise clients across pharma, biotech and life sciences, ensuring GMP, GDP, GCP, GLP compliance and leading quality transformation initiatives.

You will work on QMS design, CSV, supplier qualification, and regulatory system implementations, collaborating with client IT, regulatory and quality groups to deliver

Qualifications

• Scientific or technical background in life sciences, pharma or quality.
• Typically 8+ years in pharma/life sciences with GxP QMS transformation.
• Experience drafting and managing quality documentation including SOPs, standards, policies, forms.
• Strong knowledge of global GxP frameworks (FDA, EU GMP/EudraLex, MHRA, EMA, ICH).
• Hands-on supplier qualification, audits, CAPA and compliance management.
• Experience with RIM and PLM implementations in regulated environments.
• Knowledge of CSV and data integrity principles.
• Excellent problem-solving and stakeholder-management skills.
• QP status is desirable but not essential.
• ISO 13485 familiarity would be advantageous.

Responsibilities

• Lead design and transformation of QMS across R&D, manufacturing, clinical and distribution.
• Oversee CSV activities and data integrity controls in GxP environments.
• Support supplier qualification, audits, CAPA and risk mitigation initiatives.
• Lead RIM and PLM system implementations to improve regulatory oversight.
• Collaborate with IT, regulatory and quality teams to tailor compliant solutions.
• Engage with clients and stakeholders to deliver quality improvements.

Skills

Consultancy experience

Life sciences background

GxP regulations

SOPs & documentation

CAPA & audits

Supplier qualification

RIM implementation

PLM implementation

Data integrity knowledge

Problem solving

QP knowledge

ISO13485 familiarity

Education

Scientific background

Job description

PA Consulting in London seeks an experienced Pharma Quality Specialist Consultant to join its Life Sciences team, focusing on GxP QMS design, transformation and implementation. You will advise clients across pharma, biotech and life sciences, ensuring GMP, GDP, GCP, GLP compliance and leading quality transformation initiatives.

You will work on QMS design, CSV, supplier qualification, and regulatory system implementations, collaborating with client IT, regulatory and quality groups to deliver