Senior Director, GCP Quality

Job Description General Summary: The Sr. Director, GCP Operational Quality will advance and provide strategic direction and oversight of the strategies, mechanisms, processes and capabilities for effective and proactive quality risk management across respective product/therapeutic program area(s) (e.g.; Cystic Fibrosis). This individual will serve as the GCP Operational Quality Lead and have overall responsibility for lifecycle review of risks to quality through ensuring appropriate oversight, mitigation strategies and plans enabling clinical quality outcomes and real time inspection readiness. This individual will provide strategic oversight and leadership for Quality Management Reviews, ensuring transparency for gaining insights regarding effectiveness of risk mitigation strategies/controls, proactive and sustainable clinical quality, and compliance for assigned programs. This individual will integrate end-to-end quality principles and review preparedness at key milestones in alignment with organizational and project milestones. The Sr. Director, GCP Operational Quality will foster strong collaboration and partnership with business stakeholders and will ensure alignment with Quality leadership and teams (e.g. audit, vendor management) in development of integrated strategies for clinical programs, process and vendor oversight, inspection readiness, and assurance. This individual will provide strategic guidance and direction to the integrated benchmarking and external environmental monitoring for identifying emerging industry trends and best practices (e.g. operating models, capabilities) to facilitate maximum value to evaluation of the health of the quality system and identification of cross functional risks that will require assessment by the GXP functional areas. The Sr. Director, GCP Operational Quality will be one who has demonstrated success in engaging clinical/medical teams and cross-functional stakeholders for collaboration in applying quality risk management approaches (e.g. Quality by Design) for inspection readiness, quality outcomes and operational excellence, balancing design of models with practicality of application for effectiveness of outcomes. Key Duties and Responsibilities: Provides strategic direction and oversight to development, execution and continual improvement of quality risk management/mitigation and inspection readiness strategies across program areas Design program-specific Quality strategy and partner with business stakeholders across Global Clinical Operations, Medical Affairs, Regulatory, etc. for alignment of quality strategies, goals and approaches in support of quality outcomes and real time inspection readiness Provides strategic leadership to implementation of risk-based approaches to quality for clinical development program(s) – e.g. Quality by Design principles, risk-based quality management (RBQM) and ensure effectiveness of mechanisms for ongoing quality risk monitoring, mitigation and management Provides strategic oversight and ensures development, implementation and maintenance of the quality plan(s) summarizing the result of evidence of quality activities Leads and/or provides strategic direction/oversight to staff leading quality working groups to define integrated quality plans/activities to deliver the overall quality strategy across QA functions (e.g. audit, operations, vendor management, inspection preparedness and management, etc.) Engages and provides consultation to business partners in advancing proactive and leading quality approaches incorporating best practices and establishing/developing strategies for new models, technologies, and practices across clinical development Serves as Quality representative to cross-functional clinical development teams, R&D Leadership and quality governance bodies as applicable Manages for cause, critical and/or complex quality issues for Strategic leadership of proactive inspection readiness strategies and review at key project milestones in support of organizational deliverables and decision-making models Provides strategic direction in the oversight and continual advancement of the GCP QMS framework/model for optimizing operational performance across QA and the business areas as well as in collaboration with the Integrated QMS function in QA Leads/chairs integrated GCP QA Operational Management Reviews for ensuring cross-QA transparency and gaining insights regarding efficiency, inspection readiness, and operational performance across QA, including identification of opportunities for improvement Partners with QA leadership and managers for determination of needs for tools, metrics, mechanisms and systems enabling individual manager accountability and ownership for decision making in ensuring operational performance (budget, resource, goals/objectives) across their scope of responsibility Provides expertise and strategic oversight and direction to development and advancement of progressive models and mechanisms for risk management identification, mitigation and communications across QA supporting enhanced planning, prioritization, resourcing strategies and projection of future needs and capabilities Provides leadership coordination and direction to benchmarking with external peers and industry for establishing QA operational performance targets/goals in support of excellence, value and impact Provides leadership and partners with QA management in proactive and strategic planning for QA and translation of the strategy to operating plans for execution Partners with stakeholders across enabling functions for alignment of strategies, and optimization of programs for delivery, specifically with respect to corporate vs. QA-specific initiatives Knowledge and Skills: Broad and deep global health regulatory agency knowledge and experience across multiple GCP/PV with current knowledge of industry trends and best practices for efficiency, compliance and effectiveness Knowledge and demonstrated experience in application of risk-based quality principles (e.g. QbD) in a pharmaceutical environment Broad and deep operational and project management knowledge and experience Demonstrated strategic planning and execution skills required Proven ability to design/evolve and /or implement quality strategies and operational planning and oversight in a fit-for-purpose manner enabling effectiveness, flexibility and adaptability in a dynamic and evolving business model Current knowledge of industry trends and best practices- for progressive quality risk management in a regulated environment Developing individuals and teams; proven leadership capabilities within multi-level organization Creative, innovative leadership experience complemented with strong change management experience, adaptability, resourcefulness Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence Operational Excellence experience with proven ability to lead improvement projects-Experience with implementation and execution of program and enterprise risk management, Root Cause Analysis and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma Strong problem solving and critical thinking skills, accompanied by Analytical thinking/Data Analysis skills required to make sound decisions Education and Experience: M.S. (or equivalent degree) and 10 +years of relevant work experience, or B.S. in a scientific or allied health field (or equivalent degree) and 15+ years of relevant work experience, or relevant comparable background #LI-h