Job Title: Assistant General Manager – Late Phase QA
Company: Lambda Therapeutic Research Ltd.
Location: Ahmedabad, Gujarat, India
Job ID: 1190
Employment Type: Full-Time
CTC Range: INR 20,00,000 – 30,00,000 per annum
Experience Required: 15+ years
About the Company
Lambda Therapeutic Research Ltd. is a global full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India. The organization operates advanced research facilities across multiple global locations including Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK), and Warsaw (Poland).
Lambda provides comprehensive clinical development solutions to biotechnology companies, global pharmaceutical innovators, and generic drug manufacturers. With a strong emphasis on regulatory compliance, scientific excellence, and quality systems, the organization supports clinical trials across all phases while maintaining the highest global research standards.
Job Overview
Lambda Therapeutic Research Ltd. is seeking an experienced Assistant General Manager – Late Phase Quality Assurance to oversee quality systems and compliance activities related to late-phase clinical trials. This senior leadership role is responsible for ensuring adherence to regulatory requirements, Good Clinical Practice (ICH-GCP), organizational SOPs, and sponsor protocols.
The role involves leading quality oversight activities, conducting audits, managing CAPA processes, and supporting regulatory inspections. The selected candidate will collaborate with internal teams and external stakeholders to maintain high standards of quality management throughout clinical trial execution.
Key Responsibilities
Compile and present quality data for Quality Review Board meetings related to late-phase clinical trials, including preparation of meeting documents, minutes of meetings, and follow-up on action items.
Evaluate the effectiveness of Corrective and Preventive Action (CAPA) processes, including identification, reporting, impact assessment, and implementation.
Review clinical trial documentation to ensure compliance with regulatory standards and organizational quality systems.
Issue Quality Assurance statements and audit certificates in accordance with applicable regulatory guidelines.
Conduct routine audits (in-process, on-site, and off-site) across assigned projects to ensure trial activities, data recording, analysis, and reporting comply with regulatory requirements, client protocols, and organizational policies.
Plan and conduct system audits based on the annual audit schedule to ensure compliance with ICH-GCP guidelines, internal SOPs, and regulatory requirements.
Participate in internal project team meetings to facilitate discussions on quality management and compliance standards.
Support the Head of Quality Assurance in preparing and reviewing QA SOPs and evaluating SOPs of other departments such as Clinical Trial Management, Medical Affairs, and Medical Imaging for accuracy and compliance.
Provide audit and inspection support for assigned projects, including guidance to project teams during preparation for regulatory inspections and sponsor audits.
Assist in handling regulatory inspections and sponsor system audits by coordinating documentation, preparing data packages, and responding to regulatory queries.
Conduct retrospective audits of study protocols and study-related raw data when required.
Regularly update senior leadership on compliance levels, audit findings, and quality-related issues.
Core Competencies
Strong accountability and leadership in quality management.
Excellent work ethic and initiative in handling complex regulatory processes.
Advanced technical knowledge of clinical research quality systems.
Strong organizational and analytical skills.
Ability to align with organizational culture and quality standards.
Educational Qualification
M.Pharm or PhD in Pharmacy, Life Sciences, or related discipline.
Preferred Skills
Extensive experience in clinical research quality assurance.
In-depth understanding of ICH-GCP guidelines, regulatory compliance frameworks, and clinical trial auditing.
Experience handling regulatory inspections and sponsor audits.
Strong documentation, audit management, and CAPA handling capabilities.
How to Apply
Qualified professionals with extensive experience in clinical research quality assurance are encouraged to apply through the official Lambda Therapeutic Research careers portal or explore similar pharmaceutical and clinical research job opportunities on ThePharmaDaily.com.
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