- Coordinating the implementation of the company's quality management system pertaining to Good Clinical Practice (GCP), including oversight of external vendors, training on quality procedures, and performance monitoring against established standards.
- Serving as the main point of contact and providing support to Immunomonitoring and R&D labs, ensuring adherence to quality assurance protocols within Clinical Trials.
- Evaluating and reviewing documentation generated by internal and external parties, such as Standard Operating Procedures (SOPs) and Clinical Plans.
- Writing and/or reviewing Quality Management System (QMS) documents, including SOPs.
- Acting as the system administrator for the electronic Quality Management System (eQMS) and managing documents within the system on a day-to-day basis.
- Generating and monitoring quality metrics, including those derived from the eQMS.
- Assisting in the selection and qualification process for external vendors and providing oversight for outsourced laboratory activities.
- Supporting the planning and execution of audits, including those conducted internally, at vendor sites, clinical sites, external laboratories, and suppliers.
- Providing guidance on GCP/GCLP/GLP practices to clinical project teams and identifying/mitigating operational risks and deviations.
- Overseeing Change Controls, Deviations, and Corrective and Preventive Actions (CAPAs) related to Immunomonitoring and R&D laboratories.
- Participating in project meetings as the Clinical Quality representative, both internally and externally.
- Assisting in preparation for regulatory agency inspections and coordinating responses to any findings.
- Delivering training to laboratory teams as needed.
- Minimum 4+ years of experience in the pharmaceutical/biotechnology industry in a GCP QA role, with experience in providing quality support to clinical laboratories.
- Experience in providing quality support for Cell or Gene Therapy programs is highly desirable.
- Experience working with and managing eQMS.
- Experience conducting internal audits.
- Expert knowledge of pharmaceutical regulations, standards, and industry practices related to GCP and GCLP, with an understanding of considerations for Advanced Therapy Medicinal Products (ATMPs).
- Skilled in maintaining and monitoring a QMS, preferably in a small/start-up organization environment.
- Bachelor's Degree in Life Sciences, Pharmacy, or Regulatory.
- Understanding of immunology is desirable.
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Senior Quality Assurance Specialist - London, United Kingdom - Northreach
Description
JOB TITLE: Senior Quality Assurance Specialist
Northreach is a dynamic recruitment agency that connects businesses with top talent in the Advanced Therapies sector. Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and professional growth
I am working with a Clinical stage biotech company who're a market leader in autoimmune diseases and we're on the hunt for a Senior Clinical Quality Assurance Specialist to join a well established QA function.
KEY RESPONSIBILITIES:
Experience Needed:
Educational Requirements:
Benefits:
We offer a competitive salary package commensurate with experience, along with comprehensive benefits including medical, dental, and vision coverage, retirement plans, and opportunities for professional growth within a rapidly evolving field.
Northreach is an equal opportunity employer and we do not discriminate against any employee or applicant for employment based on race, colour, religion, sex, national origin, disability, or age. We are committed to promoting diversity, equity, and inclusion in the workplace and hiring practices, therefore only partner with business that promote DEI. We strive to create a welcoming and inclusive environment for all employees.
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