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Vice President, Quality Operations, Dry Powder Inhalation (DPI) And Soft Mist Inhaler (SMI)

Lead the establishment of quality operations for new DPI and SMI manufacturing facilities.
Durham, North Carolina, United StatesRTP, North Carolina, United States
2 weeks ago
Iviva Medical

Iviva Medical

Regenerative technologies for treating heart failure and cardiovascular diseases.

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✨ About The Role

- The Vice President will be responsible for establishing and overseeing new manufacturing facilities dedicated to Dry Powder Inhalation (DPI) and Soft Mist Inhaler (SMI) production. - This role involves ensuring that all quality operations align with global GMP/GDP standards and the company's commitment to excellence. - The VP will lead facility start-up activities and proactively shape quality systems to support long-term success. - Managing Health Authority interactions and ensuring audit readiness and regulatory compliance will be key responsibilities. - The role requires driving innovation and implementing best-in-class quality standards within the new operations.

âš¡ Requirements

- The ideal candidate will have a Bachelor's Degree in a scientific discipline and extensive experience in quality assurance and regulatory compliance. - A minimum of 15 years of experience in the pharmaceutical industry, with progressive increases in responsibility, is essential for this role. - The candidate should possess at least 10 years of management experience, including overseeing both QA and QC functions. - Strong knowledge of FDA, USP, and EP testing requirements, as well as experience in stability testing programs, is required. - The successful candidate will be highly collaborative, working cross-functionally with various teams to build a strong quality foundation.
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Vice President, Quality Operations, Dry Powder Inhalation (DPI) And Soft Mist Inhaler (SMI)
Durham, North Carolina, United States
Strategy & Ops
About Iviva Medical
Regenerative technologies for treating heart failure and cardiovascular diseases.