Sr. Executive, Documentation Management

Job Description

Azurity Pharmaceuticals is seeking a Sr. Executive, Documentation Management to maintain a robust and inspection-ready Quality Management System (QMS). This role is crucial for ensuring integrity, compliance, and continuous improvement of controlled documentation and electronic quality systems, adhering to GxP and regulatory requirements.Azurity Pharmaceuticals is a specialty pharmaceutical company focused on innovative products for underserved patients. They offer a broad commercial product portfolio and a robust late-stage pipeline, benefiting millions of patients across various markets.Responsibilities:

• Maintain and support a compliant, inspection-ready Quality Management System (QMS).
• Support the validation, integrity, and ongoing compliance of electronic quality systems.
• Support the Documentation Management System, ensuring all controlled documents are accurately managed.
• Oversee document lifecycle activities, ensuring all documentation meets GxP and regulatory standards.
• Support the development, maintenance, and delivery of a GxP training program.
• Participate in continuous improvement initiatives.
• Assist in the management and execution of the Computer System Validation (CSV) program.
• Support internal and external audits and regulatory inspections.

Requirements:

• Bachelor’s degree in Life Sciences, Pharmacy, Quality, or a related field.
• 1–3 years of experience in documentation management, quality assurance, or regulatory compliance within the pharmaceutical or biotech industry.
• Understanding of GxP principles, 21 CFR Part 11, EU Annex 11, and other applicable regulations.
• Familiarity with electronic Document Management Systems and Computer System Validation practices.
• Strong attention to detail and organizational skills.