Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.
Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.
Brief team/department description:
The Manager, Documentation Management plays a leadership role in sustaining a robust and inspection-ready Quality Management System (QMS) within a regulated pharmaceutical environment. This position is responsible for ensuring the integrity, compliance, and continuous improvement of controlled documentation and electronic quality systems, with a strong focus on adherence to GxP and regulatory requirements such as 21 CFR Part 11 and EU Annex 11.
Principle Responsibilities:
- Lead the development, implementation, and continuous improvement of a compliant, inspection-ready Quality Management System (QMS) in accordance with industry regulations and internal standards.
- Oversee the validation, integrity, and lifecycle compliance of electronic quality systems, including enterprise-wide document management platforms.
- Manage the Documentation Management System, ensuring efficient control, authorship, review, approval, and periodic revision of all controlled documents (e.g., SOPs, policies, work instructions) in alignment with lifecycle and regulatory requirements.
- Direct document lifecycle activities, ensuring timely execution and alignment with GxP standards and applicable regulatory frameworks.
- Develop and lead GxP training strategies and programs to ensure that functional teams maintain a high level of quality awareness and compliance readiness.
- Drive cross-functional continuous improvement initiatives aimed at optimizing quality system performance and documentation processes.
- Lead the planning, oversight, and execution of the Computer System Validation (CSV) program to ensure compliance with 21 CFR Part 11, EU Annex 11, and internal validation requirements.
- Serve as a point of contact for internal and external audits and regulatory inspections, ensuring documentation systems are readily accessible, compliant, and defensible.
Qualifications and Education Requirements:
- Bachelor’s degree in Life Sciences, Pharmacy, Quality, or a related field (advanced degree preferred).
- 5–7 years of progressive experience in documentation management, quality assurance, or regulatory compliance within the pharmaceutical or biotech industry.
- Strong working knowledge of GxP principles, 21 CFR Part 11, EU Annex 11, and other applicable regulatory standards.
- Proven experience managing electronic Document Management Systems and executing Computer System Validation (CSV) activities.
- Demonstrated leadership, project management, and cross-functional collaboration skills.
- Exceptional attention to detail, organizational capability, and ability to manage multiple priorities in a fast-paced, regulated environment.
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