Clinical QA Director (remote-based)

Hobson Prior are looking for a Clinical QA Director to join a brilliant organisation on a permanent basis where you will be working from home. This role will be focused on quality management and quality assurance for the clinical development programme and pre-clinical activities.

Please note that to be considered for this role you must have the right to work in this location.

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 activitiesWelcome2021.
• 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 noncompliance.
• 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 Skills:

• Attention to detail and accuracy of work.
• Excellent problem solving, written and verbal communication skills.
• Driven and perseverant.
• Self-motivated with the ability to work effectively in a dynamic environment.
• Strong track record of stakeholder management, collaboration skills and negotiation of complex situations.
• Ability to effectively manage multiple priorities with a sense of urgency.

Requirements:

• The ideal candidate will require at least of 5 years working in a GCP quality management or quality assurance position and 8 years in the pharmaceutical industry.
• The ability to effectively interact with internal cross functional teams and vendors.
• Strong experience in providing training on key quality and regulatory compliance information.
• Strong experience in inspection readiness and inspection preparedness.
• Strong experience establishing quality standards and agreements with vendors.
• Good PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).
• In-depth knowledge and understanding of relevant areas of pharmaceutical development requirements, in particular related to Phase I-III clinical trials.
• 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.
• Experience with Regulatory Inspections (e.g. FDA, MHRA, EMA, etc...) would be beneficial.
• Vendor management experience would be beneficial.
• Experience performing vendors audits and internal audits of sponsor QMS would be beneficial.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.