Job Title

Job Title GMP Quality Assurance (GMP QA) Manager Reports toHead of Quality AssuranceJOB Purpose The GMP Quality Assurance (GMP QA) Manager is responsible for overseeing and directing QA activities for new gene therapy products to ensure alignment with local and international registration requirements and company policies. The GMP QA Manager will oversee activities for manufacturing, batch record release, investigations, deviations, CAPAs (Corrective and Preventive Actions), change controls, analytical methods, stability programs, and auditing within our GMP operations.This position is in Hyderabad, INDIA (on-site). DUTIES AND RESPONSIBILITIES Quality Systems Management: Develop, implement, and maintain robust Quality Management Systems (QMS) aligned with FDA, EMA, and ICH guidelines for advanced therapy medicinal products (ATMPs). Ensure compliance with cGMP, GCP, and GLP standards across all operations. Review and Approval of Batch Record Review and Product Release: Review and approve batch records, deviations, and change controls. Support product disposition and release activities in compliance with regulatory requirements. Review and approve Certificate of Analyses against raw data and/or specifications for compliance. Review and approve various protocols and reports. Release of Ocugen-owned raw materials, packaging components, and products as needed. Review and approve project-specific procedures, protocols, and reports as needed. Regulatory Compliance: Ensure compliance with FDA, EMA, ICH, and other applicable global regulatory guidelines. Support internal audits, external audits, and regulatory inspections. Deviation and CAPA Management: Investigate deviations, non-conforming materials, out of trend, out of specifications, change controls, implement corrective and preventive actions (CAPAs), and monitor effectiveness. Training and Compliance: Develop and deliver QA training programs for staff to ensure compliance awareness. Maintain documentation and records of data integrity principles such as ALCOA++, including source data verification. Cross-Functional Collaboration: Partner with Manufacturing, QC, Regulatory Affairs, and Development teams to ensure quality standards are met throughout the product lifecycle. Continuous Improvement: Contribute to process optimization, quality enhancement, and operational excellence initiatives. Stay current with emerging manufacturing technologies, industry trends, and regulatory updates. Other Tasks: Provide guidance and assist in qualification and validation activities as needed. Quality review of regulatory filings in support of projects. Any other task assigned by the management in the manufacturing suites. Manage all the computerized systems in the manufacturing suites.3. QUALIFICATIONS Education: Bachelor’s degree in chemistry, Pharmaceutical Sciences, or a related scientific discipline.Experience: Eight plus years of QA experience in a GMP-regulated environment, preferably in cell and gene therapy. Strong knowledge of FDA, EMA, and ICH regulations for ATMPs. Experience with aseptic processing and viral vector manufacturing is highly desirable. Advanced knowledge of manufacturing, clinical, and analytical services in the pharma industry, with gene therapeutic knowledge preferred. Working knowledge of GMP, global international regulations, and ICH guidelinesSkills: Excellent understanding of QMS, risk management, and data integrity principles. Strong leadership, communication, and problem-solving skills. Ability to manage multiple priorities in a fast-paced environment.Preferred Attributes: Direct experience in managing facility and operational compliance in manufacturing. Experience with Veeva Vault electronic documentation, training, and quality systems (eQMS). Familiarity with industry standards and regulatory submissions. Ability to work in a highly collaborative and innovative environment. Strong problem-solving skills Superior project management and communication skills Attention to detail with the ability to perform a critical review of various types of documents. Strong organizational and time management skills4. WORKING CONDITIONS This job operates in an office setting and may include 5% to 10% travel for audits and/or site visits with project vendors, if needed. 5. PHYSICAL REQUIREMENTS On-site position in Hyderabad, INDIA. Standard Business Hours Primarily sedentary role.6. DIRECT REPORTS There are no direct reports.