Director, Healthcare/Ivd Quality

Site Name: UK - Hertfordshire - Stevenage, GSK HQ
Posted Date: Sep 10 2024
Job Purpose The 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 Responsibilities Serve 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. Collaborates 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 Supports evaluation of R&D to emerging Health Care Technologies and IVD regulations in our portfolio Supports issue identification, reporting, root cause analysis and CAPA development Evaluates, and/or reviews standard operating procedures and performs other activities in support of an integrated, cross functional QMS Provides matrix management and leadership to cross-functional teams Fosters a commitment to quality in individuals and a culture of quality across GKS and GSK Third Parties Responsible for quality consultation for the assigned function, program and/or Third Party Defines, implements and monitors the quality narrative/quality brief and reports any critical risk Defines the activities that need to be conducted to deliver the quality strategy for the assigned function, program and/or Third Party Supports due diligence and Merger & Acquisition activities Ensures rapid communication of quality issues and risks including potential misconduct to appropriate leaders and colleagues. Supports 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 Shares key learning's to drive simplification and replicate best practices to drive quality into the business Minimum Requirements Beachelors Degree in a Scientific Discipline Experience in invitro device regulations Experience in healthcare technologies and devices from a quality and regulatory perspective Preferred Qualifications Minimum 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 Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
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