Site Name: UK – London – New Oxford Street, UK - Hertfordshire - Stevenage Posted Date: Nov 8 2024 Are you interested in developing and delivering quality strategies in Pharmacovigilance and Lifecycle Management, ensuring regulatory compliance and patient safety? If so, the Senior Director Quality Business Partner: Pharmacovigilance and Regulatory role could be an exciting opportunity to explore. The Senior Director, Quality Business Partner, Pharmacovigilance and Regulatory is responsible for developing and delivering the quality strategy for Pharmacovigilance and Lifecycle Management activities. The incumbent manages a small team of Quality Business Partners and will provide assurance to GSK R&D senior management that GSK processes for managing safety data are effective in ensuring the integrity of the data, compliance with external regulatory requirements (EU PV Legislation, US FDA Regulations) and internal GSK requirements, and protection of patients. The position is a member of the Function & Process Quality Leadership team and with other members of the LT, responsible for the strategy and direction of this function. Application closing date: 22nd November 2024 Responsibilities include: This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Functional Expertise: Has direct accountability for the quality strategy for Safety, Regulatory and post marketing activities. 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 the global audit plan based on identified signals/trends/risks/gaps. Provide guidance and expectation to the business to build in quality by design and to enable the execution of external regulations and internal standards. Interact with executive management (QPPV, LOC, ViiV, GRA, CPO) and cross-functional business partner to identify areas of greatest quality risks and obtain information and feedback relevant to improvement. Drives issue resolution. Work with Quality Analytics to define KPI, KQI and metrics needed for QuRE and stakeholders. Ensure rapid communication of critical quality risks and issues, including potential misconduct to business partner and executive management. Supports the preparation, execution and close out of health authority inspections. Ensures ongoing inspection readiness in the area of responsibility. Provides training to QuRE and Business Partners regarding GVP, Safety and Regulatory Quality. Leadership/People Management: Build and maintain a Pharmacovigilance & Lifecycle Management Quality team by creating an environment that attracts, develops and retains high-quality employees. Provides leadership, professional development, mentoring and coaching for direct and indirect reports, including talent planning and performance management. Develop, motivate, and empower direct reports to have a high degree of accountability for performance and the oversight of key deliverables. Others: Leads multidisciplinary or cross-functional work/project teams. Provides guidance and expectations to the business to enable execution of external regulations and internal standards on a global and cross-functional level. May influence the external environment through interactions with regulators, trade associations, and professional societies. Liaise with stakeholders in R&D to understand global and local needs and determine priorities. Provide input into acceptable standards for Pharmacovigilance and Life-Cycle Management activities. Member of Global Safety Oversight & Alignment team. Serves as a member of the Functional & Process Quality leadership team setting strategies and directions for the function. Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor’s degree or equivalent in scientific or quality-related field. Experience in drug development, pharmacovigilance operations, regulatory compliance or quality management. Experience in clinical, medical, pharmacovigilance or regulatory quality. Must have operated in a senior management role with extensive supervisory/management experience. Knowledge of GCP, pharmacovigilance/drug safety and regulatory requirements. Experience leading global multidisciplinary, functional, line and matrix teams. Experience managing key stakeholders. Preferred Qualifications: If you have the following characteristics, it would be a plus: Broad working knowledge/expertise in principles and concepts of quality by design and risk management. Solid working knowledge in continuous improvement with a background in the appropriate tools. Strong quality orientation including the ability to focus on details and adherence to standards while maintaining a business perspective. Analytical mindset to develop effective quality strategies for dealing with current and future industry trends. Ability to adapt to changing direction and needs of the business; can directly apply this knowledge into daily tasks and assignments. Effective communication/negotiation skills and customer management skills. Why GSK? 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 organization where people can thrive. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. As an Equal Opportunity Employer, we are open to all talent. #J-18808-Ljbffr
