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Associate Director Quality, Operational Excellence
1 month ago
Job Description
The Quality Operational Excellence and Complaints Associate Director provides technical and strategic leadership to drive strategic change and improve operational efficiency within the cell and gene therapy business unit. 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 field
- Typically requires 8 years of experience or the equivalent combination of education and experience
- Continuous improvement experience such as six sigma or lean
- Strong technical knowledge including but not limited to: complaint process, risk management, and quality governance
- Ability to understand and translate customer needs
- Proven ability to lead improvement projects and project teams and organize various teams and forums
- Superb facilitation, Communication, and Coaching/influencing skills with proven ability to lead teams
- Proven ability to identify and analyze performance indicators.
Hybrid-Eligible Roles
In 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.
