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Director, Clinical Quality Assurance & Compliance
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- Reporting directly to the SVP Global Quality with a dotted line to the General Manager, the position is responsible for leading the Pharmaceutical Quality System (PQS) in Sharp's flagship Clinical site, implementing a Quality maturity model that focuses on prevention, fostering a Quality culture, improving customer satisfaction and driving sustainable regulatory compliance.
- This role will partner and collaborate with stakeholders across the organization to improve internal processes and governance around assessing new product opportunities, customer/product onboarding, ongoing client support, and life cycle management.
- Ensure the Quality unit delineates clear roles and responsibility and drives the 'right-sizing' of Quality Systems.
- Lead a cGMP n audit process, to include focused and general audits of Operations and Quality Assurance areas
- Ensure a robust Supplier Quality Program.
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