Head of Quality

INTRODUCTION

i-Pharm Consulting are working exclusively with an established mid-sized CRO who require an ambitious Clinical QA professional to join their team as a Head of QA. This permanent opening will provide high levels of role diversity and provide the opportunity to develop skillsets in the full GxP scope, alongside the conventional areas GCP Quality, Compliance and Research Governance.

JOB SUMMARY

• Exciting mid-sized CRO
• Established clinical portfolio
• Excellent internal support networks
• Opportunity to take the lead on commercial and strategic activities
• Input to overall QA strategy
• Highly competitive remuneration package

TITLE

• Head of QA

LOCATION

• Cheshire, UK

RESPONSIBILITIES

• Responsible for the development and continuous improvement of quality systems and SOPs
• Taking part in required GCP site and vendor audits when required
• Hosting internal audits
• Participate in MHRA/FDA inspections, providing guidance and expertise to the existing quality structure
• Development and continuous improvement of a robust QMS system
• Maintaining the business' ISO:9001 certification
• Responsible for efficient and effective QA documentation processes
• Ensuring smooth study start-up and continued efficiency of clinical trials from a Quality perspective
• Preparing and managing overall Quality budget

REQUIREMENTS

• Relevant Life Sciences degree
• 5+ years' clinical QA roles within CRO/Pharma/Biotech environment
• Strong knowledge and experience of GCP compliance (wider GxPs a bonus)
• Experience of working within larger Phase II / III clinical trials
• Excellent communication skills, both orally and written

About i-Pharm Consulting

i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the UK and Europe. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance, Validation and Bioinformatics.
www.i-pharmconsulting.com


TO APPLY

If you would like to discuss this vacancy further, please call Senior Consultant Dominic Williams on +44 (0)20 3873 7066, or email dwilliams@i-pharmconsulting.com. If this role is not suitable, Dominic is also available to discuss other possible positions or answer any general questions regarding your career and the current market.

KEY WORDS

CAPA / Quality Systems / QMS / Audit / Auditor / GxP / GDP / GCP / GMP / GLP / SOP writing / SOP / SAE / Quality Assurance / QA / GCP Audit / QA specialist / QA Manager / Quality Assurance / QA Leader / Quality Manager / Senior Manager / Senior Management / Pharmaceutical / Site Audit / Internal Audit / External Audit / ICH-GCP / Good Distribution Practice / Risk / Risk Management / General Data Protection Regulations / GDPR / E6 (R2) / Clinical QA / CQA / Root Cause Analysis / RCA / England / Wales / Scotland / Ireland / London / Liverpool / Manchester / Cheshire / Merseyside / Warrington / Stockport / Runcorn / Bury / Sale / Macclesfield / Chester / Wrexham / Nantwich / Northwich / Crewe / Altrincham