Assistant General Manager – Late Phase QA
Lambda Therapeutic Research | Ahmedabad, India
Req ID: 1190
Date Posted: 26 November 2025
Experience Required: 15+ years
Education Required: M.Pharm / Ph.D.
Salary (CTC): INR 20,00,000 – 30,00,000 per annum
Location: Ahmedabad, Gujarat
Department: Late Phase Quality Assurance
Company Overview
Lambda Therapeutic Research Ltd. is a global full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India. With advanced research facilities across India, USA, Canada, Spain, UK, and Poland, Lambda provides comprehensive end-to-end clinical development services for innovator, biotech, and generic pharmaceutical companies worldwide.
The organization is recognized for its scientific expertise, operational excellence, and commitment to delivering high-quality clinical research outcomes.
Role Overview
The Assistant General Manager – Late Phase QA will lead quality oversight for late-phase clinical trials, ensuring adherence to global regulatory standards and organizational SOPs. This senior position demands strong expertise in GCP compliance, quality systems, audit management, and cross-functional coordination across clinical and medical operations.
This is a strategic leadership role designed for highly experienced QA professionals looking to contribute to global late-phase research quality and operational governance.
Key Responsibilities
Quality Governance & Data Oversight
Lead data compilation for Quality Review Board meetings for late-phase clinical trials.
Manage meeting preparation, documentation, minutes of meeting (MOM), and follow-up of action items.
Review CAPA effectiveness including identification, reporting, root-cause assessment, and implementation.
Audit & Compliance
Issue QA statements and audit certificates in alignment with regulatory guidelines.
Conduct process, in-process, on-site, and off-site audits to ensure trial compliance with regulatory requirements, SOPs, protocols, and client specifications.
Perform system audits as per the annual audit calendar, ensuring adherence to ICH GCP, Lambda SOPs, quality systems, and regulatory frameworks.
Cross-Functional Collaboration
Participate in project team meetings and lead quality-related discussions.
Support Head-QA in developing and reviewing QA SOPs and system SOPs for clinical trial management, medical affairs, and medical imaging.
Provide guidance to project teams during audit and inspection readiness activities.
Regulatory & Sponsor Interface
Support regulatory inspections and sponsor audits, including data preparation and response management.
Coordinate with internal teams for regulatory or sponsor queries related to clinical trials or medical imaging.
Conduct retrospective audits of study protocols and raw data whenever required.
Reporting & Continuous Improvement
Provide regular updates to Head-QA regarding compliance levels, audit outcomes, and emerging quality concerns.
Promote a culture of accountability, quality excellence, and continuous improvement across the QA function.
Required Competencies
Strong accountability and ownership
High work ethic and integrity
Leadership and initiative in quality operations
Deep technical knowledge of late-phase clinical research and GCP
Ability to fit and contribute to Lambda’s global organizational culture
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Auckland |New Zealand :
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Tartu | Estonia |Harju County (Maakond) :
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Kyiv |Lima Region :
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