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Senior Manager, Quality Systems

On-site Full-time

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Experience Level

Senior Level Manager

Qualifications

Key Responsibilities:Oversee the development, implementation, and continuous improvement of a compliant, inspection-ready Quality Management System (QMS) aligning with industry regulations and internal standards. Ensure effective documentation management and quality assurance processes to meet compliance objectives. Collaborate with cross-functional teams to promote a culture of quality and compliance throughout the organization.

About the job

Azurity Pharmaceuticals is a dynamic, privately held specialty pharmaceutical company dedicated to creating innovative solutions for underserved patients. As a pioneer in developing unique, high-quality medications, we leverage a comprehensive integrated approach and a wide-reaching partner network to enhance our expansive commercial product portfolio and late-stage pipeline. Our patient-centered products address critical needs in cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, positively impacting millions of lives. Discover more at www.azurity.com.

At Azurity Pharmaceuticals, we embrace diversity and pride ourselves on being an Equal Opportunity Employer. Our remarkable success is driven by our talented and committed team, who strive to improve patient lives through a commitment to scientific excellence and quality in every aspect of our work. We are looking for driven individuals who embody dedication, integrity, and innovation to join our team.

 

Team/Department Overview:

Job Type: Full-Time

The Senior Manager of Quality Systems plays a crucial role in maintaining a robust, inspection-ready Quality Management System (QMS) within a regulated pharmaceutical environment. This position is accountable for ensuring the integrity, compliance, and continuous enhancement of controlled documentation and electronic quality systems, emphasizing adherence to GxP and regulatory standards such as 21 CFR Part 11 and EU Annex 11.

About Azurity Pharmaceuticals

Azurity Pharmaceuticals is a cutting-edge specialty pharmaceutical company committed to delivering innovative therapeutic solutions that cater to the unique needs of underserved patient populations. We excel in developing and providing high-quality medications through strategic partnerships and a robust commercial pipeline, ultimately enhancing patient care across various therapeutic areas.

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