Hobson Prior are seeking a GLP/GCP Quality Compliance Lead/Specialist to join a fantastic biotech organisation on a permanent basis located in London. Our client is focused on people who live with critical illnesses and manufacturing probable restorative remedies for them.

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

Key Responsibilities:

• For this position, you will be accountable for providing QA oversight, technical QA expertise, support and leadership across the Pre-Clinical and Clinical Operations.
• Responsible for analysis and reporting of clinical quality KPI and data to identify potential trends and risks and producing metrices to the senior leadership.
• Guarantee the compliance of clinical operations and preclinical Quality systems used therein.
• Function intimately with clinical and pre-clinical teams.
• Utilise audit and inspection intelligence and risk mitigation plans to assure adherence to GCPs in the conduct of clinical trials, the quality and integrity of generated data and welfare and rights of subject safety.
• Act as QA GLP/GCP representative during Regulatory Inspections and 3rd party audits.
• Direct and complete audits including audits of clinical investigator sites, third parties, clinical trial master files, contributing scientist reports, clinical summary reports, and final reports, supporting operations related to GCP, GPvP, GCLP, and GLP.
• Manage the clinical and preclinical operations internal and external audit programme.
• Operate globally to assure clinical studies are performed to all local regulatory requirements.
• Operate in alignment with the QMS lead and other QA teams to assure interfaces are maintained.
• Provide GCP/GLP training to staff.
• Maintain an awareness and thorough understanding of new GCP/GLP regulatory requirements and assure the QMS incorporates these as required in timely fashion.
• Cooperate with clinical and preclinical operations, offering quality oversight of internal and external clinical and preclinical activities.
• Collaborate with clinical and preclinical functions to ensure compliance with all applicable regulations and standards.
• Act as a technical resource to resolve GCP/GLP issues based on knowledge of regulation s, guidelines, and relevant SOPs.

Requirements:

• A Bachelor's degree in life science or corresponding.
• Solid and palpable track record of GCP and GLP auditing experience of Early and Late Phase clinical trials within Pharma.
• Knowledge holding sponsor audits and regulatory inspections.
• Experience leading GCP inspection readiness activities.
• Knowledge with gene or cell therapy auditing programmes is preferred.
• Evident experience in a quality management system position in the pharmaceutical or other regulated industry.
• Capability in a body of information required for the job e.g. knowledge of EU, FDA and global regulations, for GCP, GLP, GPvP, and GCLP.
• A high degree of flexibility and capacity to adjust to altering priorities.

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.