Associate Director, QA Operations

RXinsider LTD.; Hyderabad; On-site; INR 3,000,000 - 6,000,000; Full time

Job summary

Azurity Pharmaceuticals is seeking an Associate Director to manage QA Operations internationally, ensuring compliance with US FDA, EU GMP, Health Canada, PIC/S and GDP. This role supports global quality operations including deviation handling, CAPA management, change control, and technical batch release as applicable.

You will lead QA oversight for CMOs and 3PLs, manage a team, and collaborate with Regulatory, Supply Chain, and Technical Operations to ensure in-market product release and

Qualifications

• Minimum 10 years in pharmaceutical Quality Assurance / QA Operations.
• Experience managing external pharmaceutical manufacturing partners (CMOs).
• Team management experience.
• Working knowledge of Veeva Quality Vault (Quality Management System) is beneficial.

Responsibilities

• Lead QA oversight for CMOs, 3PLs and other vendors internationally, including deviation/OOS assessment, change control, and CAPA evaluation.
• Oversee batch disposition documentation 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.
• Oversee Quality Management System for assigned vendors: 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
• Conduct GMP/GDP audits of CMOs, 3PLs, and other vendors.
• Participate in local risk management and escalation processes aligned with global procedures.
• Lead continuous improvement and training of QA personnel related to regulatory/compliance requirements.
• Lead a team of QA Operations personnel.

Skills

QA Operations

CMO management

Team management

Veeva Quality Vault

Quality Assurance

Education

Bachelor's degree in Pharmacy / Chemistry / Biology

Tools

Veeva Quality Vault

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 an Associate Director to manage 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

• Lead QA oversight for assigned CMOs, 3PLs and other types of vendors based Internationally, including deviation/OOS assessment, change control, and CAPA evaluation.
• Oversee 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.
• Oversee Quality Management System for assigned vendors: 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
• Conduct GMP/GDP audits of CMOs, 3PLs, and other vendors.
• Participate in local risk management and escalation processes aligned with global procedures.
• Lead continuous improvement and training of QA personnel related to regulatory/compliance requirements.
• Lead a team of QA Operations personnel.

Required Skills And Experience

• Minimum 10 years in pharmaceutical Quality Assurance / QA Operations (QC experience would be eligible)
• Previous experience in managing external pharmaceutical manufacturing partners (CMOs).
• Team management experience.
• 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.