Senior Clinical Quality Assurance Specialist in London - Northreach

Job Description Northreach is a recruitment agency that connects businesses with top talent in the cell & gene therapy, fintech, and digital sectors. Our mission is to provide clients and candidates with a seamless and personalised recruitment experience and create a positive work environment that encourages equality, innovation, and professional growth.

We are long standing partners with a well known Biotechnology company based in London, looking for a Senior Quality Assurance Specialist to join their team. This successful candidate will be reporting to the Senior Clinical Quality Assurance Manager coordinate the implementation of the company quality management system relevant to GCP (including laboratory analysis of clinical samples) including external vendor oversight, training on quality procedures and monitor performance against agreed standards.

RESPONSIBILITIES
Serves as main point of contact and support for Immunomonitoring and R&D labs. Provides support and back-up to Senior Clinical Quality Assurance Manager in quality assurance aspects of the Clinical Trials.
Evaluates and/or reviews documentation generated by internal or external parties (e.g. SOPs, Essential documents, Clinical Plans).
Writes and/or reviews QMS documents (e.g. SOPs).
Act as system administrator for eQMS and perform day-to-day management of documents within the system.
Generation and monitoring of quality metrics including those from the eQMS.
Assists with the selection and supports the qualification process for selected external vendors and provides oversight for outsourced contracted laboratory activities.
Supports the Senior Clinical Quality Assurance Manager in the planning and conduct of audits, including internal, vendors, clinical sites, external laboratories, suppliers.
Provides support to establish fit for purpose practices that ensure traceability and data integrity for internal laboratories in particular those analysing clinical patient samples.
Provide GCP/GCLP/GLP guidance as appropriate to clinical project teams, including risk identification/mitigation of potential of identified operational issues/deviations.
Oversees, manages and provides input as needed for Change Controls, Deviations and CAPAs in relation to the immunomonitoring and R&D laboratories. Participates in project meetings (internal and external) as Clinical Quality representative, as required.
Assists in inspection readiness preparation, and/or directly supports regulatory agency inspection. Assists in coordination of response to any findings.
Deliver training to laboratory teams as required.
Deliver eQMS training to users as required.
Assist in the archiving of GxP documentation and act as a deputy Company Archivist.
Promote quality culture and one of continuous improvement.

EXPERIENCE, TECHNICAL & EDUCATIONAL REQUIREMENTS
Experience
Min 4+ years of experience in pharmaceutical/biotechnology industry in a GCP QA role, including experience of providing quality support or oversight to Clinical laboratories.
Experience of providing this Quality support for Cell or Gene Therapy programmes is highly desirable.
Experience of working with and managing eQMS.
Experience of providing quality support or oversight to Clinical laboratories.

Technical Requirements
Experience of conducting internal audits
Expert knowledge of pharmaceutical regulations, standards, and current industry regulatory practices related to GCP and GCLP with an understanding of the considerations for ATMP’s
Experience of eQMS’s including set up and administration
Skilled at maintenance and monitoring of a QMS preferably including experience in a small/ start-up organisation environment.
Experience in archiving is desirable

Educational Requirements
Bachelor’s Degree in Life Sciences, Pharmacy, Regulatory
Understanding of immunology is desirable

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.