Pharma Quality & Compliance Consultant — QMS Transformation (Hybrid)

PA Consulting; Melbourn; Hybrid; GBP 90,000 - 130,000; Full time

Benefits offered by this job

Health and lifestyle perks

Private healthcare

25 days annual leave

Company pension

Annual performance-based bonus

PA share ownership

Cycle to work / Give as you earn

Job summary

PA Consulting is seeking an experienced Pharma Quality Specialist Consultant to join its Life Sciences team. The role focuses on designing and transforming GxP‑compliant QMS across R&D, manufacturing, and distribution, with strong emphasis on regulatory compliance and data integrity.

You will lead CSV and data integrity activities, support supplier qualification and audits, and work with Regulatory Information Management (RIM) and PLM systems to enable end‑to‑end product data control.

Qualifications

• Management consultancy experience highly desirable.
• A scientific or technical background in life sciences, pharmaceutical sciences, quality or related discipline.
• Typically 8+ years’ experience within pharmaceuticals 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 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.

Responsibilities

• Design and implement GxP‑compliant QMS across R&D, manufacturing, clinical and distribution environments.
• Conduct process mapping and gap assessments, and support rollout of new or enhanced systems aligned to regulatory standards.
• Author, review and maintain quality policies, standards, SOPs, forms and controlled documentation.
• Support effective change management by collaborating with quality, technical and business teams.
• Lead CSV activities and develop validation strategies, protocols, test scripts and data integrity controls.
• Support supplier qualification, audits, CAPA and ongoing risk mitigation.
• Lead the implementation and optimisation of Regulatory Information Management (RIM) systems and PLM.
• Engage with clients and regulators; provide SME on GxP regulations and inspection readiness.
• Act as QP for product certification and release where appropriate.
• Translate regulatory expectations into practical process improvements and drive cross‑functional delivery.

Skills

Management consultancy

Scientific background

Life sciences knowledge

Education

Life sciences degree

Job description

PA Consulting is seeking an experienced Pharma Quality Specialist Consultant to join its Life Sciences team. The role focuses on designing and transforming GxP‑compliant QMS across R&D, manufacturing, and distribution, with strong emphasis on regulatory compliance and data integrity.

You will lead CSV and data integrity activities, support supplier qualification and audits, and work with Regulatory Information Management (RIM) and PLM systems to enable end‑to‑end product data control.