Manager, QA Operations

About the Role

Azurity is seeking a Manager to execute QA Operations internationally to ensure full compliance with US FDA, EU GMP, Health Canada, PIC/S and GDP regulations and guidelines. As part of these core responsibilities, this role will support Global Quality Operations including deviation/OOS assessment, CAPA management, change control, PQR reviews, product complaints, performance of vendor audits, and technical batch release, as applicable.

Key Responsibilities

• Execute QA oversight for assigned CMOs, 3PLs and other types of vendors based Internationally, including deviation/OOS assessment, change control, and CAPA evaluation.
• Perform technical documentation for batch disposition (e.g. batch record reviews, CoAs, deviation/OOS investigation reports, stability data) to support in-market product release.
• Ensure quality processes align with international standards and local market requirements.
• Collaborate with Supply Chain, Regulatory, Technical Operations, for the supply of medicinal products to the various markets.
• Manage assigned vendors for Quality Systems - deviation investigation, CAPAs, change control management, product quality reviews (PQRs), compliance risk assessment, self-inspections, and Quality Technical Agreements.
• Support inspections from the local Health Authorities and follow-up actions.
• Support GMP/GDP audits of CMOs, 3PLs, and other vendors, if required.
• Participate in local risk management and escalation processes aligned with global procedures.
• Execute continuous improvement and training of QA personnel related to regulatory/compliance requirements.

Required Skills and Experience

• Minimum 5 years in pharmaceutical Quality Assurance / QA Operations (QC experience would be eligible)
• Previous experience in managing external pharmaceutical manufacturing partners (CMOs).
• Working knowledge of Veeva Quality Vault (Quality Management System) is beneficial.

Preferred Qualifications

• Degree in pharmacy, chemistry, or biology or any other related science background.