Associate Director, QA Operations
Azurity Pharmaceuticals is seeking an Associate Director to lead Quality Assurance (QA) Operations at its Hyderabad, India location. This role is integral to ensuring compliance with international regulatory standards, including those set by the US FDA, EU GMP, Health Canada, PIC/S, and GDP. The successful candidate will oversee global quality operations, manage vendor relationships, and contribute to the company's mission of delivering high-quality medications to underserved patients.
The Associate Director will be responsible for leading QA oversight for assigned Contract Manufacturing Organizations (CMOs), Third-Party Logistics providers (3PLs), and other international vendors. Key duties include assessing deviations and out-of-specification results, evaluating change controls and corrective and preventive actions (CAPAs), and overseeing technical documentation for batch disposition. The role also involves ensuring that quality processes align with international standards and local market requirements, collaborating with cross-functional teams to support the supply of medicinal products, and conducting GMP/GDP audits of vendors.
Candidates should possess a minimum of 10 years of experience in pharmaceutical Quality Assurance or QA Operations, with eligibility for those with Quality Control experience. Prior experience managing external pharmaceutical manufacturing partners is essential, along with team management experience. Familiarity with Veeva Quality Vault or similar Quality Management Systems is beneficial. A degree in pharmacy, chemistry, biology, or a related scientific field is preferred.
Azurity Pharmaceuticals offers a dynamic work environment focused on innovation and quality. Employees have opportunities for professional growth and development within a company dedicated to improving patient outcomes through accessible and high-quality medications. The organization values integrity, dedication, and a collaborative spirit, making it an ideal workplace for motivated individuals seeking to make a meaningful impact in the pharmaceutical industry.