Associate Director - Quality, Oncology EMU, Waltham, MA
Site Name: USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence Posted Date: Oct 19 2021 Oncology is a core area of intensive focus at GSK, and while much progress has been made in the past few years, more can be done to REDEFINE EXPECTATIONS in cancer care. As we look to redefine expectations in oncology, we need experienced, entrepreneurial-minded leaders to help us on this journey. The Experimental Medicine Unit (EMU) Quality team is seeking an Associate Director - Quality, Oncology EMU. The EMU is responsible for biomarker and diagnostic activities within Oncology R&D at GSK. This position will support the development and oversight of a fit-for-purpose Quality Management System for the EMU, ensuring that policies, procedures and systems are implemented in alignment with Global GSK quality standards and applicable regulatory requirements. Key responsibilities include: Support the development and oversight of a fit-for-purpose Quality System for the Oncology Experimental Medicine Unit (EMU) Manage the development of site-level SOPs, Work Instructions, Guidance Documents, other controlled documents in harmonization with the GSK Quality System. Oversight of the EMU Issue Management process to ensure quality related issues are reported, assessed, resolved, and/or escalated in a timely manner Support the internal audit program for critical EMU processes including third party oversight, biomarker assay validation, etc. Support audit and inspection readiness activities Manage site-level department training curricula and generate training compliance reports Develop, monitor and report Quality metrics for EMU activities including clinical trial specimen management, clinical biomarker/diagnostic testing, external partner Key Performance Indicators (KPI's), sample bank, etc. Perform gap assessments to identify compliance risks and opportunities for improvement; communicate and remediate gaps Support Enterprise-wide quality and risk management workstreams Other duties, as required Why you? Basic Qualifications: BS/MS/PhD degree in Engineering, Life Sciences or equivalent experience required 7+ years in Quality, Compliance or equivalent experience in a regulated setting required (i.e. Pharma, Biotech, IVD, Medical Device, etc.) Preferred Qualifications: Experience managing Quality Systems / Processes preferred Experience with biomarker and diagnostic assay development in drug clinical trials highly desirable Knowledge / experience with global and local quality standards and regulations highly desirable: 21 CFR Part 820 Good Clinical Practice (GCP) CAP / CLIA In Vitro Diagnostic Regulation (IVDR) ISO 15189 ISO 13485 Why GSK? As GSK Focuses on Our Values And Expectations And a Culture Of Innovation, Performance, And Trust, The Successful Candidate Will Demonstrate The Following Capabilities Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigor and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. 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