Deputy Manager – Quality Assurance
Lambda Therapeutic Research | Ahmedabad, India
Job ID: 1270
Location: Ahmedabad, India
Experience Required: 8–12 years in Late-Phase Quality Assurance
Educational Qualification: M.Pharm
Salary (CTC Range): INR 8,00,000 – 12,00,000 per annum
Posted On: 15 November 2025
About Lambda Therapeutic Research
Lambda Therapeutic Research Ltd. is a global full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India. With operations across Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK), and Warsaw (Poland), the organization delivers comprehensive end-to-end clinical research services to innovator, biotech, and generic pharmaceutical companies worldwide.
Lambda has established itself as a trusted CRO partner by maintaining high scientific standards, regulatory compliance, and operational excellence across early-phase, late-phase, and post-approval clinical research programs.
Role Overview
The Deputy Manager – Quality Assurance will oversee quality compliance for late-phase clinical research projects. This role is responsible for ensuring that all trial-related activities are conducted, recorded, analyzed, and reported in accordance with applicable regulatory requirements, organizational SOPs, and sponsor expectations. The position also involves mentoring junior team members, participating in internal quality discussions, and supporting audit and inspection readiness for global studies.
Key Responsibilities
Audit Oversight and Compliance
Conduct routine in-process, on-site, and off-site audits for assigned late-phase projects.
Verify compliance with regulatory standards, organizational SOPs, protocol requirements, and client specifications.
Perform retrospective audits of critical study documents such as informed consent forms, project plans, IMP plans, IMP release checklists, safety management plans, and clinical study reports.
Team Leadership and Mentorship
Supervise junior QA team members and provide training, guidance, and performance support.
Facilitate quality-focused discussions during internal project meetings.
Regulatory and Sponsor Support
Provide support for regulatory inspections and sponsor audits by preparing data, documentation, and responses.
Assist the Head of QA in coordinating inspection logistics and addressing regulatory or sponsor queries related to clinical trials or medical imaging.
Quality Systems and Continuous Improvement
Execute system audits according to the annual audit calendar to ensure adherence to Lambda SOPs and global regulatory requirements.
Support quality analysis, trending, and tracking of open issues to drive timely resolution.
Contribute to the enhancement of organizational quality frameworks and compliance systems.
Experience Requirements
8 to 12 years of experience in Late-Phase Quality Assurance within a CRO or pharmaceutical environment.
Strong understanding of GCP, global regulatory guidelines, audit methodologies, and quality systems.
Educational Qualification
M.Pharm or equivalent advanced degree in Life Sciences.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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