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Associate Director Quality Assurance
4 months ago
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 ResponsibilitiesnFit for purpose and phase appropriate processes within the PQS including establishing processes for the qualification and approval of vendors and suppliers.nProcesses 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.nRisk based and phase appropriate Quality input to risk assessment for materials used in manufactured products.nAs 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 partynMaintain and manage the External Audit Schedule for the organisationnRoutine 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 includednQuality 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.nMonitor 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.nReview and approve Quality and GxP related documentationnHead 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.nIn inspection readiness preparation, and/or directly supports regulatory agency inspection. Assists in coordination of response to any findings.nQuality culture and one of continuous improvement within team, site and suppliers as appropriate
Experiencen10+ 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)nCommunication 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 issuesnExperience of GCP, GLP and/or GCLP auditing an advantagenExperience in performance of effective external audits and ensuring effective follow up
Educational RequirementsnDegree in a biological science, chemistry or equivalentnAuditor course certification or equivalent
