Hobson Prior are looking for a Director Clinical QA to join a brilliant biotech organisation on a permanent basis located in London. Our client is focused on developing solutions that might possibly be the cure for those who suffer from severe illnesses.

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

Key Responsibilities:

• Maintain QMS compliance.
• Encourage a "Quality Mindset" with peers and stakeholders by offering proactive guidance on GLCP regulations and QMS.
• Provide oversight and support in the area of CQA (Clinical Quality Assurance) to the Pre-Clinical and Clinical Operations teams.
• Provide oversight of third-party vendors and suppliers such as CROs and CMOs for CQA purposes, and follow up on their performance.
• As a Quality Assurance (QA) representative, provide clinical teams with input and guidance on compliance throughout the lifecycle of the project, in clinical project meetings..
• Be responsible for overseeing clinical quality matters such as regulatory submissions, clinical protocols, and the conduct and reporting of clinical trials in the capacity of QA lead.
• Contribute to the selection and ongoing auditing of key suppliers, vendors, CROs, and CMOs.
• Implement a system for supporting and/or executing audits, e.g., site, vendor, process, system, regulatory submission, clinical trial documents.
• Manage Clinical Review Board Escalation for critical clinical quality incidents.
• Host regulatory inspections within GCP requirements and remediate findings promptly.
• Communicate with global QA colleagues to ensure consistent application of Quality strategy, and promote business standardisation.
• Assist pre-clinical and clinical senior management and staff in ensuring compliant performance of clinical studies.
• Provide training and mentorship, develop and deliver awareness sessions on various GLCP topics.
• Maintain Data Integrity and Good Documentation Practice (GDocP) in accordance with applicable procedures and ensure own work and that of the team complies.
• Ensure that own training and that of the team is completed in a timely and compliant manner before a task is undertaken.
• Manage KPIs, plans, targets, and objectives according to deadlines.
• Assist other members of the Global Quality Leadership Team when needed

Key Skills:

• The ability to demonstrate and ensure that clinical trials sponsored by are compliant with GCPs, GLPs, and quality risk management principles.
• Knowledge of pharmaceutical quality assurance for GCP and GLP within a clinical trial and operations environment.
• Expertise in developing simple, robust and compliant Quality Management Systems in accordance with GCLP regulations.
• Knowledge and experience in GCP and GLP auditing requirements as a Lead Auditor.
• Having a good understanding of the quality standards for preclinical research and good practices.
• CRO experience or knowledge of working with CROs.
• Experience preparing, hosting, and following up on regulatory inspections.
• Expert in quality requirements, research, product development activities, and commercialization who has been part of senior management teams and contributes to the development and implementation of operational strategy.
• The ability to interpret complex data and present key findings.
• Ability to build a "Quality Mindset" for team members who haven't worked within a GxP environment.

Requirements:

• A degree in a science-based field, such as a Bachelor of Science (BSc) or a Master of Science (MSc).
• Experience in senior management roles within pharmaceutical/biopharmaceutical companies' Quality Assurance GCP/GLPP functions.
• A comprehensive understanding and application of GCP/GLP regulations, as well as substantial experience defining and harmonising Quality Management Systems, with a proven track record of implementing them successfully.
• The ability to establish and maintain effective working relationships with peers and stakeholders on an internal and external level.
• Having experience hosting and following up on corporate audits, client audits, and regulatory inspections.

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.

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