Job Title : Quality Assurance Manager / Sr. Quality Assurance Specialist
ABout The Company:
Ocugen is currently looking for a Quality Assurance Manager / Sr. Quality Assurance Specialist to join our team. As a key member of the organization, you will play a crucial role in fostering a culture of quality, efficiency, and excellence. Your responsibilities will include ensuring that quality and compliance are integrated into our day-to-day operations and long-term Quality strategy. You will collaborate cross-functionally to identify and remediate compliance gaps and contribute to the continuous improvement of our quality systems. This is an exciting opportunity to make a significant impact on the success of our vaccine, cell, and gene therapy product portfolio.
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.Duties and Responsibilities
- QA lead for Ocugen’s cross-functional team of R&D, Quality & External Manufacturing, QA and QC teamsReview and approve master batch records and executed batch records, batch release and disposition for clinical use
- Engage in review and approval of Quality System recordsincluding deviations, CAPAs, change controls, participate or facilitate FMEA/Root cause analysis as appropriate and assess product quality impact.
- Ensure Deviations, CAPAs & investigations are closed out within the required timeframe
- Inspect and release GMP raw materialsfor onsite GMP facility and review & approve external GMP raw materials for quality and compliance to US FDA and EMA regulatory standards
- Provide hands-on QA support and oversight to internal staff, suppliers / contractorsto ensure adherence to SOPs and relevant Good Regulated Practice (GxP) requirements
- Review and grant final approval to system lifecycle documentationincluding URS, Validation Plans, Qualification Protocols, Qualification Summary Reports, and Requirements Traceability Matrices
- Participate in the remediation of deviationsidentifying compliance gaps, and advising on changes to existing systems
- Attend project meetingsoffering valuable feedback and guidance on any QA-related issues
- Review and approve analytical methodsmethod 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 auditsvendor / supplier audits, planning, execution and reports
- Maintain QA dashboardsto 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
Qualifications
- Master’s Degree & 4 years of experience
- Bachelor’s degree preferably in Chemistry, Microbiology, or related sciences with 5 years of experience
- Strong knowledge of ICH guidelines, cGMPs, US FDA regulations and guidelinesfor 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
