A leading biopharmaceutical company that develops cancer treatments is currently recruiting a GCP QA Manager to join their office in Cambridge. Proclinical is pleased to announce this exciting opportunity to work with a company that operates across the United States, Europe, and other international markets with an extensive pipeline of products in development.
The GCP QA Manager will work closely with the Senior Manager of GCP-CO, Clinical Teams, and Quality Assurance at the Direction of the Senior Director of GCP-CO to manage and support a culture of quality, regulatory compliance, and continuous inspection readiness across clinical development functions. They will support the Clinical Development organisation by contributing to the definition, implementation, and support of processes that build quality into clinical trial operations and ensure continuous inspection readiness.
Job Responsibilities:
- Interprets clinical trial regulations and guidelines, leveraging expertise, experience, and critical thinking skills to provide routine and urgent guidance to stakeholders.
- Represents GCP-CO at clinical project team meetings and other cross-functional meetings and discussions, making decisions or providing provisional recommendations as warranted.
- Leads Clinical Quality Team (GCP-CO and GCP-QA) quarterly meetings on a rotating basis.
- Leads assigned projects of varying complexity related to proactive GCP compliance oversight.
- Recognizes and reports quality issues for assigned clinical studies and functional areas.
- Performs GCP Risk Assessments, Reports Internal Deviations, Facilitates Root Cause Analyses, and advises on content of non-audit CAPAs and audit report responses.
- Leads or participates in GCP noncompliance/Serious Breach investigations, depending on breadth and complexity.
- Recommends and drives operational and compliance-related process improvements by leading or participating in process improvement / best practice working groups.
- Creates tools (e.g., worksheets, instructions, or trackers) to ensure successful completion of deliverables related to compliance, inspection readiness, and regulatory authority requests.
- Leads inspection preparation meetings for assigned clinical project teams (e.g., CRO document readiness, storyboarding, training).
- Works with CROs and functional areas within the company as needed to obtain or prepare study documents required for Inspection.
- Participates in regulatory inspections as facilitator of back room processes and activities; performs other inspection tasks such as document retrieval and review, tracking of inspection requests, interpreting scribe notes.
- Participates in developing and implementing inspection preparation strategies and activities.
- Conducts ad-hoc site visits to assess inspection readiness and prepare investigators and staff for interaction with regulatory inspectors.
- Develops content and delivers presentations for investigator meetings, business partners, and other events.
- Writes and delivers presentations on GCP-related topics for investigator meetings and other events.
- Writes and reviews Clinical Operations and Cross-Functional SOPs; leads SOP development teams, may train stakeholders on critical or complex procedures.
- Reviews clinical documents (e.g., protocols, clinical study reports, informed consent forms, etc.) for compliance with regulations, regulatory guidelines, and SOPs.
- Advises on eTMF content and process.
Skills and Requirements:
- A Bachelor's degree.
- Previous background or experience (5-10 years) in clinical operations, quality assurance, clinical compliance, regulatory, or scientific/health care field is preferred.
- Advanced knowledge of ICH GCP guidelines, and FDA Code of Federal Regulations for clinical research, experience with other international regulations preferred.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Katty Maia at + 442038543317 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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