Nom du site: UK - Hertfordshire - Stevenage, GSK HQ
Date de publication: Sep 10 2024
Job PurposeThe purpose of the role is to be the quality advocate for their given area of responsibility. The role provides strategic, expert advice and consultation on R&D quality with impact across the Good Practices. The role will educate assigned groups on Quality by Design, GxP risk minimization and mitigation; and will help the business and GSK's Third Party partners understand potential impact of Quality risks and alternatives to best address the risk.
Key ResponsibilitiesServe as the quality business partner for assigned GSK R&D functions, programs and/or Third Parties supporting Health Care technologies, Invitro devices (IVD's) and lab methods.Work closely with business and/or Third Party teams to provide expert quality information, manage identified issues and support continuous improvement particularly in scope of Health Care Technologies, IVDR and clinical lab regulations.Collaborate with the Audit, Inspection, Risk and Issue Management teams within R&D Quality and Risk Management function on all internal quality audits, regulatory agency inspections, risk assessments, issue and CAPA activities.Support evaluation of R&D to emerging Health Care Technologies and IVD regulations in our portfolio.Support issue identification, reporting, root cause analysis and CAPA development.Evaluate and/or review standard operating procedures and perform other activities in support of an integrated, cross functional QMS.Provide matrix management and leadership to cross-functional teams.Foster a commitment to quality in individuals and a culture of quality across GSK and GSK Third Parties.Responsible for quality consultation for the assigned function, program and/or Third Party.Define, implement and monitor the quality narrative/quality brief and report any critical risk.Define the activities that need to be conducted to deliver the quality strategy for the assigned function, program and/or Third Party.Support due diligence and Merger & Acquisition activities.Ensure rapid communication of quality issues and risks including potential misconduct to appropriate leaders and colleagues.Support the investigations of potential serious breaches and critical issues.Participate in special assignments on various projects and workstreams as determined by R&D Quality and Risk Management LT.Share key learnings to drive simplification and replicate best practices to drive quality into the business.Minimum RequirementsBachelor's Degree in a Scientific Discipline.Experience in invitro device regulations.Experience in healthcare technologies and devices from a quality and regulatory perspective.Preferred QualificationsMinimum 8 years in drug development, regulatory compliance or quality management.Minimum 3 years in clinical, medical, pharmacovigilance or regulatory quality.Demonstrated knowledge of GLP, GCP, GVP and regulatory requirements.
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