Quality Assurance Manager

Axygen Pharmatech is a leading Contract Quality Organization (CQO) and training partner, assisting the pharmaceutical and biotech industries in achieving top-tier compliance, quality, and workforce readiness. Headquartered in Hyderabad, India, we provide comprehensive support across the product quality lifecycle, including auditing, regulatory compliance consulting, remediation, training, and talent solutions. Leveraging AI-driven tools and a Global Centre of Excellence, we empower companies to meet rigorous global regulatory requirements and foster a culture of quality. Axygen is dedicated to building long-term partnerships that enhance compliance and transform organizations worldwide through innovation, integrity, and excellence.

This is a full-time on-site role for a Quality Assurance Manager based in Hyderabad. The Quality Assurance Manager will oversee and implement quality systems to ensure compliance with regulatory standards and internal processes. Responsibilities include monitoring and improving quality processes, conducting audits, leading CAPA initiatives, ensuring inspection readiness, and providing team training to uphold consistent compliance with global GxP standards. The role also involves collaborating across departments to maintain operational excellence and support organizational goals.

• Proven experience in Quality Assurance, GMP/GxP Compliance, and regulatory compliance
• Strong expertise in auditing, inspection readiness, and corrective and preventive actions (CAPA)
• Knowledge of regulatory requirements from USFDA, EMA, WHO, CDSCO, and MHRA
• Ability to develop and deliver effective training programs aligned with regulatory standards
• Strong organizational, analytical, and problem-solving skills
• Effective communication, leadership, and team management skills
• Proficiency in using data-driven tools and AI-enabled dashboards for quality management
• Bachelor's or Master's degree in a relevant field (Life Sciences, Pharmacy, or related discipline)
• Experience in the pharmaceutical or biotech industries is highly desirable