Senior Global QA Director (GCP)

INTRODUCTION

i-Pharm Consulting are working exclusively with highly-regarded full-service mid-sized CRO who are looking to acquire an experienced GCP leader to direct and strategically develop their global QA function.

JOB SUMMARY

• Exciting mid-sized CRO
• Excellent reputation and global market perception
• Opportunity to lead and develop cross-functional clinical teams
• Take the lead on technical, commercial and strategic activities
• Creation and development of global QA culture
• Highly competitive remuneration package

TITLE

• Senior QA Director (GCP)

LOCATION

• Home-based, UK

RESPONSIBILITIES

• Responsible for the development and performance of international QA teams in support of the Executive team
• Ensuring that important business-critical QA decisions are made within relevant guidelines and regulations (ICH, FDA regulations, European, MHRA)
• Developing and managing overall annual QA budget
• Subject Matter Expert on all Quality matters and CAPAs within the organisation's global QMS
• Manage the Key Quality Indications for the related Therapeutic Areas
• Implementation of risk management strategies across international teams and clinical trials
• Issue global management meetings with Functional Area Representatives for the delivery of key reports, insights and trends
• Subject Matter Expert on all Quality Management Documents and documentation processes
• Responsible for efficient and effective QA documentation processes

REQUIREMENTS

• Relevant Life Sciences degree
• 5+ years working at Director level within a GCP QA role
• 15+ years' experience within Quality Assurance
• Thorough knowledge and experience of GCP compliance (wider GxPs a bonus)
• Demonstrated knowledge of 21 CFR Part 11 regulations
• Accomplished communicator when dealing with both internal / external stakeholders
• Ability to motivate, direct and influence global teams

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 / Berkshire / Hertfordshire / Cambridgeshire / Hampshire / Merseyside / Cheshire / Manchester / Lancashire / Yorkshire / Surrey / Essex