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…