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My client is a pioneering Biotech whose ambitions are to deliver innovative & life changing therapies to patients for a range of autoimmune and inflammatory diseases. They have a unique T-cell based technology that they are harnessing to develop the next generation of therapies that are about to enter the clinic and have an expanding pipeline.
Overview:
You will provide Quality and Compliance support to clinical trials being conducted by our client as well as supporting their laboratories. With strong GCP and some GCLP/GLP knowledge, you will help establish and manage the Quality System as it relates to GCP, including writing, reviewing, approving and/or maintaining Standard Operating Procedures and other clinical documentation. You will work closely with the Clinical team to provide oversight of external vendors and to address any quality related issues as well as providing support to internal laboratories undertaking analysis of clinical trial samples to help establish best practice and ensure integrity of data.
Responsibilities:
• Serve as the Clinical Quality lead for clinical trial programs.
• Ensures compliance of clinical studies with internal SOPs and clinical plans as well as global regulations.
• Evaluate, write and/or review documentation generated by internal or external parties.
• Contribute to the quality management system.
• Ensure clinical quality requirements are fit for purpose and are appropriate to the clinical phase.
• Assists with the selection and qualification for selected external vendors and provide oversight for outsourced contracted clinical activities.
• Establishes audit plans and lead audits.
• Provides support to establish best practice to ensure traceability and data integrity for internal laboratories, in particular those analysing clinical patient samples
• Provide GCP/GCLP/GLP guidance.
• Identifies and monitor quality indicators and data to identify potential trends and risks to patient safety, compliance, data integrity or to the business and promote improvements.
Qualifications/Experience required:
• Experience in pharmaceutical/biotechnology industry in a GCP QA role
• Experience of conducting internal and external audits
• Experience of Vendor oversight especially CRO’s, external contract laboratories
• Experience or understanding of Quality support for Cell or Gene Therapy programmes is highly desirable
• Experience supporting Clinical Quality laboratories would be advantageous
• Skilled at maintenance and monitoring of a QMS preferably including experience in a small/ start-up organisation environment.
• Understanding of immunology is desirable
Expired
- Location: Greater London
- Salary: DOE plus generous benefits including bonus and flexible working.
- Job Type:Permanent
Posted over 2 years ago
- Sector: Quality, Clinical Operations
- Contact: Alex Butcher
- Contact Email: alex.butcher@nextphaserecruitment.com
- Contact Phone: 01403 216216
- Start Date: 2021-07-26
- Job Ref: V-46958
Overview:
You will provide Quality and Compliance support to clinical trials being conducted by our client as well as supporting their laboratories. With strong GCP and some GCLP/GLP knowledge, you will help establish and manage the Quality System as it relates to GCP, including writing, reviewing, approving and/or maintaining Standard Operating Procedures and other clinical documentation. You will work closely with the Clinical team to provide oversight of external vendors and to address any quality related issues as well as providing support to internal laboratories undertaking analysis of clinical trial samples to help establish best practice and ensure integrity of data.
Responsibilities:
• Serve as the Clinical Quality lead for clinical trial programs.
• Ensures compliance of clinical studies with internal SOPs and clinical plans as well as global regulations.
• Evaluate, write and/or review documentation generated by internal or external parties.
• Contribute to the quality management system.
• Ensure clinical quality requirements are fit for purpose and are appropriate to the clinical phase.
• Assists with the selection and qualification for selected external vendors and provide oversight for outsourced contracted clinical activities.
• Establishes audit plans and lead audits.
• Provides support to establish best practice to ensure traceability and data integrity for internal laboratories, in particular those analysing clinical patient samples
• Provide GCP/GCLP/GLP guidance.
• Identifies and monitor quality indicators and data to identify potential trends and risks to patient safety, compliance, data integrity or to the business and promote improvements.
Qualifications/Experience required:
• Experience in pharmaceutical/biotechnology industry in a GCP QA role
• Experience of conducting internal and external audits
• Experience of Vendor oversight especially CRO’s, external contract laboratories
• Experience or understanding of Quality support for Cell or Gene Therapy programmes is highly desirable
• Experience supporting Clinical Quality laboratories would be advantageous
• Skilled at maintenance and monitoring of a QMS preferably including experience in a small/ start-up organisation environment.
• Understanding of immunology is desirable