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Quality Assurance Manager / Sr. Quality Assurance Specialist at Ocugen

About Ocugen

Ocugen is a leading biopharmaceutical company focused on developing novel treatments for various diseases. With a strong commitment to quality and compliance, we strive to make a positive impact on patients’ lives. Our India office in Hyderabad plays a crucial role in our global operations.

Job Details

Job Location: India Office – Hyderabad


Job Purpose

The Quality Assurance Manager / Sr. Quality Assurance Specialist is responsible for fostering a culture of quality, efficiency, and excellence ensuring that quality and compliance are integrated into the day-to-day operations and long-term Quality strategy. This role works closely with Head of Regulatory Affairs & Quality Assurance to support quality activities for Ocugen’s vaccine, cell and gene therapy product portfolio. This role focuses on the validation and qualification of equipment, systems, and manufacturing processes, along with providing oversight to project teams. The Quality Assurance Manager / Sr. Quality Assurance Specialist will collaborate cross-functionally to identify and remediate compliance gaps and contribute to the continuous improvement of our quality systems.

Job title is commensurate with experience and skills.

Duties and Responsibilities

QA lead for Ocugen’s cross functional team

  • Review and approve master batch records and executed batch records, batch release and disposition for clinical use

Quality System Records

  • Engage in review and approval of Quality System records, including deviations, CAPAs, change controls, participate or facilitate FMEA/Root cause analysis as appropriate and assess product quality impact

Deviations, CAPAs & Investigations

  • Ensure Deviations, CAPAs & investigations are closed out within the required timeframe

GMP Raw Materials

  • Inspect and release GMP raw materials for onsite GMP facility and review & approve external GMP raw materials for quality and compliance to US FDA and EMA regulatory standards

QA Support and Oversight

  • Provide hands-on QA support and oversight to internal staff, suppliers / contractors to ensure adherence to SOPs and relevant Good Regulated Practice (GxP) requirements

System Lifecycle Documentation

  • Review and grant final approval to system lifecycle documentation, including URS, Validation Plans, Qualification Protocols, Qualification Summary Reports, and Requirements Traceability Matrices

Remediation and Changes

  • Participate in the remediation of deviations, identifying compliance gaps, and advising on changes to existing systems

Project Meetings

  • Attend project meetings, offering valuable feedback and guidance on any QA-related issues

Analytical Methods and Reports

  • Review and approve analytical methods, method qualification / validation protocols and reports, stability protocols and reports, shelf-life extensions, generation of certificates of analysis as needed, shipment of product to the clinical sites for subject dosing and reconciliation of unused vials


  • Participate in internal and external periodic audits, vendor / supplier audits, planning, execution and reports

QA Dashboards and Metrics

  • Maintain QA dashboards to track and monitor all quality milestones, work with consultants for quality events trending and metrics, and assist the quarterly management review of quality trend reports


  • Master’s Degree & 4 years of experience or Bachelor’s degree preferably in Chemistry, Microbiology, or related sciences with 5 years of experience in cGMPs related to Biologics, Vaccine, and/or Cell and Gene therapy products
  • Strong knowledge of ICH guidelines, cGMPs, US FDA regulations and guidelines for manufacturing and testing of Biologics / Vaccines / Cell & Gene therapies for clinical studies
  • Experience leading Deviations, CAPA reviews, and investigations
  • Experience with compiling and presenting departmental Key Performance Indicator metrics to leadership
  • Fluent in English, excellent oral and written communication skills
  • Strong attention to detail, meticulous while reviewing critical documents, and ability to lead others in a team setting
  • Experience working with consultants and CDMOs


Keywords: Quality Assurance Manager, Sr. Quality Assurance Specialist, Ocugen, Vaccine, Cell and Gene Therapy, Quality Systems, Compliance, cGMP, Biologics, ICH guidelines, US FDA regulations, Quality Metrics

Shekhar Suman is the Co-founder of BioTecNika Info Labs Pvt. Ltd. He is an Entrepreneur, Writer, Public Speaker, and a Motivational Coach. In his career, he has mentored more than 100,000+ students toward success in the Biopharma Industry. He heads the BioTecNika Group, which comprises BioTecNika.com, BioTecNika.org, and Rasayanika.com. An avid reader and listener who is passionate about BioSciences. Today Biotecnika is India's largest Biotech Career portal, with over 5 Million subscribers from academia & Industry. It's ranked among the top 50 websites worldwide in the Biology category.