Azurity Pharmaceuticals
Manager,QAOperations
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optimal for Manager candidates.
“Manager, QA Operations at Azurity Pharmaceuticals. Skills: QA Operations, Vendor management, Regulatory compliance. Execute QA oversight for assigned CMOs, 3PLs and. Assess deviations and OOS”
Industry & Context.
Deviation assessment; OOS assessment; CAPA management; Risk management
What They're Looking For.
Must Have
5 years in pharmaceutical Quality Assurance / QA Operations, Experience managing external pharmaceutical manufacturing partners (CMOs)
Nice to Have
Degree in pharmacy, chemistry, or biology, Working knowledge of Veeva Quality Vault
What You'll Do.
Execute QA oversight for assigned CMOs
Assess deviations and OOS
Manage change control
Perform technical documentation for batch disposition
Review deviation/OOS investigation reports
Review stability data
Ensure quality processes align with international standards
Ensure quality processes align with local market requirements
Collaborate with Supply Chain
Collaborate with Regulatory
Collaborate with Technical Operations
Manage assigned vendors for Quality Systems
Manage deviation investigation
Manage change control management
Manage product quality reviews (PQRs)
Manage compliance risk assessment
Manage self-inspections
Manage Quality Technical Agreements
Support inspections from local Health Authorities
Follow-up on inspection actions
Support GMP/GDP audits of CMOs
Participate in local risk management processes
Participate in escalation processes
Execute continuous improvement of QA personnel
Execute training of QA personnel
How You'll Work.
Team & Collaboration
Supply Chain; Regulatory; Technical Operations
Full Job Description
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. 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 wit
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