QA Consultant (GCP)

Walker Cole International is currently partnered with a Biopharmaceutical business who is on the trajectory for continued growth. To support the exceptional increase in workload and plans for growth, we are searching for an oncoming hire of a QA Consultant (GCP) in the UK for a contract of 12 months initially for 2025.

The ideal candidate will have the following responsibilities:

• Review and oversee GCP operations and documentation across clinical studies, protocols, monitoring plans, and vendor records.
• Conduct gap assessments on existing QA processes (including SOPs, change control, training, deviation and CAPA systems) aligned to FDA, EMA, ICH, and MHRA expectations.
• Develop, implement, and maintain SOPs, training programs, and corrective actions to close compliance gaps.
• Lead and support mock audits, internal/external audits, and inspection readiness activities, including preparation for FDA submissions and regulatory inspections
• Establish and manage vendor qualification and oversight programs, including KPI tracking, auditing of CROs/labs, and ensuring GCP-aligned vendor compliance
• Act as QA lead in cross‑functional project teams, collaborating with Clinical, Regulatory, Medical Affairs, and R&D to ensure quality compliance.
• Prepare and present audit reports, quality metrics, CAPA summaries, and risk escalations to senior management.

The ideal candidate will have the following skills/experience:

• In depth knowledge and experience of both QA and GCP
• Can-do attitude and eager to learn
• Availability from 2025 onwards

Contract details:

• Start date: 2025 
• 5 days per week 
• Hybrid
• £100 p/hr (dependent on experience level)
• Duration of project: 12 months (with possible extension)
• Location: UK

QA l Quality Assurance l Quality l GCP l Good Clinical Practice l Change Control l Clinical l Contract l Contractor l CAPA l  Biopharma l Pharma