Senior Director of Quality Assurance
Position Overview : We are looking for a Senior Director of Quality Assurance with 15+ years of experience to lead our client's quality transformation, starting with sites in the northeast US.
The candidate must have deep expertise in GMP and experience in manufacturing plants within the pharma or CMO industry. This role requires someone who can drive urgent change and lead the implementation of a new QMS, supporting the client through significant remediation actions.
Key Responsibilities :
- Lead and manage the client's quality remediation actions, including addressing hundreds of existing issues and ensuring progress on multiple new items added weekly.
- Oversee the implementation of a modern, compliant QMS, and manage quality processes such as deviations, investigations, change controls, and CAPA.
- Partner with the project lead to drive quality improvements across US sites, with plans to expand internationally.
- Manage inspections, audits, and regulatory interactions, ensuring compliance with FDA requirements and mitigating the risk of warning letters.
- Collaborate with other leaders to foster a culture of quality and continuous improvement, emphasizing data integrity and modern practices.
Qualifications :
- 15+ years of experience in QA with a deep understanding of GMP in the pharma or CMO industry.
- Proven ability to lead quality transformations in a manufacturing environment.
- Experience in handling large-scale remediation efforts and familiarity with quality processes from deviations to root cause analysis.
- Strong leadership skills to manage resistance and cultural shifts, especially in an organization transitioning from long-standing practices.
- Ability to work closely with senior leaders to drive quality changes under tight deadlines.
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