Associate Director Quality, Operational Excellence
3 days ago
This position focuses not just on the “what” but the “how”.
This role will also be responsible for the complaints process.
Key Duties and Responsibilities:Collaboration and Integration: Serve as an integrator across multiple functions, fostering collaboration and knowledge sharing.
Develop partnerships across the organization to drive collective learning.Drive performance optimization, continuous improvement, and operational excellence.
Apply expertise to develop solutions, streamline operations, and enhance productivity.Responsible for all activities associated with the product complaint process, including reconciliation training, complaint sample management, triage, trending, and SOP management, etc.Processes incoming clinical and commercial production complaints including intake, initial evaluation, and triage.
Coordinates with CMOs for external investigations including root cause analysis and corrective actions.Work with global quality and functional areas to ensure processes are scalable and flexible including integration of new modalities into the quality systems as Vertex expands its scope of operations.Proactively identify ways to improve efficiency and effectiveness of processes which may include quality system process improvements, improving existing methodologies, data generation, report development and presentation
Requirements:Bachelor's degree in a scientific discipline, operations research, operations management, business administration or a related fieldTypically requires 8 years of experience or the equivalent combination of education and experienceContinuous improvement experience such as six sigma or leanStrong technical knowledge including but not limited to: complaint process, risk management, and quality governanceAbility to understand and translate customer needsProven ability to lead improvement projects and project teams and organize various teams and forumsSuperb facilitation, Communication, and Coaching/influencing skills with proven ability to lead teamsProven ability to identify and analyze performance indicators.
Hybrid-Eligible RolesIn this Hybrid-Eligible role, you can choose to be designated as:Hybrid:
work remotely up to two days per week;
or select
On-Site : work five days per week on-site with ad hoc flexibility.
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