Associate Director Quality Assurance
2 weeks ago
We are working with a partner who seek to deliver truly innovative, life-changing therapies for our patients. Our vision as a company is to build a major global biopharmaceutical company bringing transformational and valued therapies for a range of autoimmune and inflammatory diseases, as well as preventing rejection in organ transplantation, based on modular engineered Tregs.
The Role - ASSOCIATE DIRECTOR QC (EXTERNAL QUALITY)
To lead Quality Assurance and Compliance activities associated with external providers of materials or services required in the day-to-day activities associated with GMP production activities or the conduct of clinical trials.
This includes quality support for the selection, qualification and oversight of CDMO’s and other providers of GxP services and raw or starting materials. Establish and manage processes within the Quality System as it relates to relevant vendors across the organisation and develop and lead External Audit Schedule.
Main Responsibilities
* fit for purpose and phase appropriate processes within the PQS including establishing processes for the qualification and approval of vendors and suppliers.
* processes for the routine quality monitoring and oversight of Suppliers in conjunction with members of Supply Chain and operational leads (material or service users)
* the qualification process for material and service providers once selected.
* risk based and phase appropriate Quality input to risk assessment for materials used in manufactured products.
* as the primary contact for quality related matters (including working closely with Person In Plant as available) associated with external vendors, leading the communication between quality representatives of each party
* maintain and manage the External Audit Schedule for the organisation
* routine QA duties to ensure manufacturing and testing activities that are outsourced comply with GxP
* or review Quality (Technical) Agreements to ensure they are established and appropriate with critical vendors
* to the review of contracts, MSA, SOW to ensure GxP and Compliance elements have been included
* quality support to ensure starting materials are procured, tested and imported as required according to UK HTA requirements
* and monitor the elements of the PQS relating to external quality activities including; change controls, deviation & CAPA, quality risk management, vendor qualification, vendor complaints.
* monitor and present quality indicators/KPI’s for external vendors to assess performance and identify potential trends and risks to patient safety, compliance, data integrity or to the business and promote continuous improvement initiatives by the Vendors to improve product or service quality.
* review and approve Quality and GxP related documentation
* Head of Quality and Senior Management of significant quality related matters/risks that could impact patient safety, product quality, product release, regulatory compliance or be considered a business risk.
* in inspection readiness preparation, and/or directly supports regulatory agency inspection. Assists in coordination of response to any findings.
* quality culture and one of continuous improvement within team, site and suppliers as appropriate
Experience
* years Significant Experience in Quality Assurance in a GMP manufacturing environment (in particular small scale e.g. ATMP’s, clinical trials or individualised patient products is desired)
* communication skills with the ability to collaborate, deal with conflicts and work effectively with external suppliers
* of managing external suppliers and in the resolution of Quality related issues
* experience of GCP, GLP and/or GCLP auditing an advantage
* experience in performance of effective external audits and ensuring effective follow up
Educational Requirements
* Degree in a biological science, chemistry or equivalent
* Auditor course certification or equivalent
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