Team Lead TA Quality (Senior Director)

GlaxoSmithKline
United States, Massachusetts, Cambridge
Nov 21, 2024
Site Name: USA - Pennsylvania - Upper Providence, Durham Blackwell Street, UK - Hertfordshire - Stevenage, UK - London - New Oxford Street, USA - Massachusetts - Cambridge, USA - Massachusetts - Waltham Posted Date: Nov 7 2024 Team Lead, TA Quality Job Purpose The position is responsible for leading a team of Quality Business Partner that deliver independent quality expert support to stakeholder. The incumbent is a member of the QBP Therapeutic Area LT and provides input into the quality strategy of this function. The position is responsible for ensuring that quality is designed into programs and projects across therapeutic areas and for defining quality activities that ensure submission and inspection readiness. Key Responsibilities *Functional Expertise:* Continually evaluate the strategic approach, drive changes in R&D QuRE processes and modify the quality strategy and plan to meet the changing needs to the organization, regulatory requirements, and industry best practices. Identify and drive continuous quality improvements as a consequence of risk assessments, audits, inspections, trends/metrics and root cause analysis. Provides input into global audit plan based on identified signals/trends/risks/gaps. Ensure rapid communication of critical quality risks and issues, including potential misconduct to business partner and QuRE management. Drive Quality by Design implementation on an asset level. Supports the preparation, execution and close out of health authority inspections. Demonstrates implementation of quality strategy to health authorities Participate/ provides expertise in Due Diligence (in-licensing activities) as applicable. *Leadership/People Management* Lead a team of QBP that provides experienced quality support for development (and life-cycle projects). Responsible for talent development, career development, and performance management to ensure resources are appropriately attracted, developed and deployed to deliver the quality strategy. Support the development of annual goals and objectives supporting the strategy. Contributes to the review and revision of the R&D Quality and Risk Management strategy. Leads and/or support functional initiatives as assigned. *Other* Maintains the highest level of awareness, expertise in international GLP, GCP and GVP regulations, and internal policies and SOPs. May influence the external environment through interactions with regulators, trade associations or professional societies WHY YOU? Basic Qualifications Bachelor's degree in scientific or quality-related field Experience in pharmaceutical industry and/or quality assurance. Experience in an international environment leading global quality team; previous supervisory/management experience. Experience of principles and concepts of quality assurance, (quality) risk management, and quality by design Experience of GLP, GCP, pharmacovigilance/drug safety and regulatory requirements, as well as analytical, organisational, and planning skills Experience in the areas of oncology, immunology, respiratory, vaccine Preferred Experience / Qualifications Bachelor's degree or equivalent in scientific or quality-related field or equivalent combination of education, training and experience. Experience in supporting regulatory authority inspections. Knowledge of Risk-based quality management, root cause analysis and quality narrative/briefs concepts and methodology Digital savviness, experience with AI/ML and data analytics Ability to work effectively in an international multicultural matrix organization. Effective communication/negotiation skills and customer management skills Experience with Veeva QMS, CTMS and Doc Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. 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). Our success absolutely depends on our people. 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