Manager, QA Operations

Azurity Pharmaceuticals is seeking a Manager to execute Quality Assurance (QA) Operations internationally, ensuring full compliance with US FDA, EU GMP, Health Canada, PIC/S, and GDP regulations and guidelines. This role is integral to the Global Quality Operations team, supporting the company's commitment to delivering high-quality medications to underserved patients.

The Manager will oversee QA activities for assigned Contract Manufacturing Organizations (CMOs), Third-Party Logistics providers (3PLs), and other international vendors. Key responsibilities include assessing deviations and Out-of-Specifications (OOS), managing Change Control and Corrective and Preventive Actions (CAPA), reviewing Product Quality Reviews (PQRs), handling product complaints, conducting vendor audits, and facilitating technical batch releases. Collaboration with Supply Chain, Regulatory, and Technical Operations teams is essential to ensure the seamless supply of medicinal products to various markets.

Candidates should possess a minimum of 5 years of experience in pharmaceutical Quality Assurance or QA Operations, with eligibility for those with Quality Control (QC) backgrounds. Experience in managing external pharmaceutical manufacturing partners (CMOs) is required. Familiarity with Veeva Quality Vault or similar Quality Management Systems is beneficial. A degree in pharmacy, chemistry, biology, or a related science field is preferred.

Azurity Pharmaceuticals offers a dynamic work environment focused on innovation and quality. Employees are encouraged to engage in continuous improvement initiatives and receive training related to regulatory and compliance requirements. The company values dedication, integrity, and a creative spirit, providing opportunities for professional growth and development within the organization.