Clinical (GCP) Quality Manager

Clinical (GCP) Quality Manager

Job Title: GCP Quality Manager

Location: London

Job Type: Permanent

Job Conditions: Full Time, 40 hours a week

A leading specialty pharmaceutical company focused on addiction and drug overdose have an exciting opportunity for a Clinical (GCP) Quality Manager.

Job Summary

As the Clinical (GCP) QA Manager you will assist in the definition, implementation, and maintenance of the Quality Management System in conjunction with company policies, global & local regulatory requirements and ICH GCP / GxP standards.

Responsibilities

• Ensure compliance, consistency and support to improve and standardise the key operational activities with quality processes, standards and outcomes
• To regularly communicate and collaborate with functional areas to develop strong working relationships and provide the project quality support
• Cooperate with Clinical Operations and Project Management teams to provide the quality support and help resolve audit findings and quality issues
• Promote quality approach cross-functional teams in a matrix system
• Identify the potential challenges, propose solutions and advocate the proactive engagement
• Support the audits and perform TMF quality control (focusing on completeness, accuracy, timeliness)
• Create and maintain strong data alignment between internal and external sources of quality data
• Identify compliance gaps and make recommendations for the quality programmes and continuous improvement initiatives
• Create and review assigned Standard Operating Procedures (SOPs) in conjunction with the relevant regulations and standards
• Carry out the assignments to the standards of high quality, efficiency, innovation, accuracy, integrity and safety in accordance with company and regulatory requirements
• Conduct additional activities as assigned

Requirements

• Minimum 3 years' Quality experience (auditing, quality oversight, QMS) working in Pharmaceutical, Biotechnology and/or CRO company
• Bachelor's degree in Pharmaceutical or Science discipline as a minimum
• Strong knowledge of QMS complexity with a practical understanding of global and local requirements and ICH GCP/GxP standards
• Proven track record of delivering continual process improvement in systems and processes
• Strong logical and analytical thinking skills
• Experience in internal, external and/or system auditing would be an advantage

About i-Pharm Consulting

i-Pharm Consulting is a specialist Recruitment Company servicing the global Pharmaceutical industry. 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 and Bioinformatics.

www.i-pharmconsulting.com

Apply Now

For more information on this role and a full job description or an informal discussion, please email Joysel Livelo on jlivelo@i-pharmconsulting.com or reply with your CV for immediate consideration.