Director of Clinical Quality Management

A growing biotech company are seeking a Director of Clinical Quality Management to focus on quality management and quality assurance for the clinical development programme and pre-clinical activities.

This person serves as SME in good clinical practice GCP and oversees GLP and GVP quality management. The role executes all quality assurance and quality management activities within the scope of GCP QA.

This role will suit a driven candidate who is self-motivated with the ability to work effectively in a dynamic environment, maybe someone looking to step up into their first Director-level role. The position is home-based, with monthly trips to London for team meetings.

The role is responsible to develop a culture of quality and provide guidance, training and overall support to the company with respect to compliance with applicable international regulations, practices and guidelines. This person will work closely with all levels of Development, Research and QA functions and acts as the company’s compliance officer, with responsibility for QA department budgets, and up to 3 reports.

Key Responsibilities:

• Develop GCP Quality and Compliance processes for the sponsor quality management system (QMS) (e.g., revise existing procedural documents, facilitate development of new processes and policies, initiate process improvement work streams)

• Manage quality and compliance aspects of clinical development processes, including procedural document review, creating and administering training, handling process deviations, and performing internal audits

• Oversee and manage GCP, GLP, and GVP quality assurance and auditing (including management and oversight of consultants)

• Primary company contact for quality questions and issues related to non-clinical and clinical activities

• Act as Company Compliance Officer, serving as escalation point for quality issues and reports issues and quality metrics to the Management team

• Manage non-compliance assessment, investigation, root cause analysis, reporting, and CAPA, including serious breach of GCP, data privacy breach, and other serious non-compliance

• Lead the clinical audit programme for vendor qualification and monitoring, as well as clinical sites and internal audits (involves management and oversight of clinical auditor)

• Work closely with Clinical Operations on vendor qualification, vendor agreements, establishment of key quality metrics, vendor management and oversight, and issue escalation

• Perform review and QC of clinical trial documents

• Perform ongoing risk-assessments and mitigation activities

• Report on quality activities and metrics to management

• Maintain up to date regulatory intelligence and provide advice and briefings on pharmaceutical standards and regulations to support company activities

• Support and coordinate with Manufacturing Quality in management of GMP activities, where appropriate

• Support regulatory inspection preparedness activities

Key Requirement:

• Minimum of 5 years working in a GCP quality management or quality assurance position and 8 years in the pharmaceutical industry

• Extensive understanding of international requirements of Good Clinical Practice (GCP) and ICH E6 R2 Guidelines plus working knowledge of national/international regulations applicable to the conduct of clinical trials in the UK, EU, and US

• In-depth knowledge and understanding of relevant areas of pharmaceutical development requirements, in particular related to Phase I-III clinical trials.

• Experience in providing training on key quality and regulatory compliance information

• Ability to effectively interact with internal cross functional teams and vendors

• Experience in inspection readiness and inspection preparedness

• Experience establishing quality standards and agreements with vendors

• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint)

 • Understanding of international requirements of GVP and GLP guidelines, plus working knowledge of national/international regulations applicable to the conduct of non-clinical and clinical trials in the UK, EU, and US

• Experience with Regulatory Inspections (e.g. FDA, MHRA, EMA, etc...)

• Vendor management experience

• Experience performing vendors audits and internal audits of sponsor QMS

If you have the essential skills required and would like to discuss the full detail of the Job Description, required competencies, and remuneration, please contact Katie Dunbar on +441293 584300, or apply with your CV to arrange a confidential discussion.