Job Title: Assistant General Manager – Late Phase Quality Assurance (QA)
Job ID: 1190
Location: Ahmedabad, Gujarat, India
Department: Late Phase QA
Employment Type: Full-Time
CTC Range: INR 20 – 30 Lacs per annum
Company Overview
Lambda Therapeutic Research Ltd. is a global full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India. With international operations across India, USA, Canada, Spain, UK, and Poland, Lambda delivers comprehensive clinical research solutions to innovator, biotechnology, and generic pharmaceutical companies worldwide. The organization is recognized for its regulatory excellence, robust quality systems, and end-to-end clinical development expertise.
Job Summary
Lambda Therapeutic Research Ltd. is seeking an experienced Assistant General Manager – Late Phase QA to lead and strengthen quality assurance oversight across late phase clinical trials. This leadership role is responsible for ensuring regulatory compliance, audit readiness, CAPA effectiveness, and adherence to ICH-GCP and global regulatory standards.
The position requires strategic quality leadership, regulatory inspection management experience, and strong expertise in clinical trial quality systems within a CRO or pharmaceutical environment.
Key Responsibilities
Quality Oversight & Governance
Compile and present data for Quality Review Board meetings for late phase trials and associated functions.
Prepare meeting documentation, Minutes of Meeting (MOM), and track action item follow-ups.
Evaluate the effectiveness of CAPA management including identification, reporting, impact assessment, and implementation.
Issue QA statements and audit certificates in accordance with applicable regulatory guidelines.
Clinical Trial Audits & Compliance
Conduct routine in-process, on-site, and off-site audits across assigned projects.
Ensure all trial-related activities, data recording, analysis, and reporting are compliant with regulatory, organizational, and client requirements.
Perform system audits as per annual audit calendar to ensure adherence to ICH-GCP, internal SOPs, quality systems, and applicable regulations.
Conduct retrospective audits of study protocols and raw data as required.
Regulatory Inspection & Sponsor Audit Support
Support preparation and coordination of regulatory inspections and sponsor system audits.
Arrange documentation and respond to regulatory and sponsor queries related to clinical trial and medical imaging activities.
Coordinate cross-functional readiness for inspections and audits.
SOP & Quality System Management
Assist Head-QA/Designee in preparation, review, and revision of QA SOPs.
Review system SOPs across departments such as Clinical Trial Management, Medical Affairs, and Medical Imaging for adequacy and compliance.
Participate in key internal project meetings and facilitate quality-focused discussions.
Regularly update senior QA leadership on compliance status and key risk areas.
Required Qualifications
M.Pharm or Ph.D. in Life Sciences, Pharmacy, Clinical Research, or related discipline.
Experience Required
Minimum 15+ years of experience in Clinical Quality Assurance within a CRO, pharmaceutical, or clinical research environment.
Proven experience in late phase clinical trial audits and regulatory inspections.
Strong exposure to ICH-GCP guidelines, global regulatory frameworks, and quality systems management.
Core Competencies
Clinical Quality Assurance Leadership
ICH-GCP and Global Regulatory Compliance
CAPA Management & Risk Assessment
Audit & Inspection Readiness
SOP Development & Quality System Governance
Strong accountability, initiative, and technical expertise
High ethical standards and organizational alignment
SEO & GEO Optimized Keywords
Assistant General Manager QA Jobs Ahmedabad, Late Phase Clinical QA Careers, CRO Quality Assurance Leadership Roles, ICH GCP Audit Jobs India, Clinical Trial Quality Management, Regulatory Inspection Support Careers, Pharmaceutical QA Jobs Gujarat
Why Join Lambda Therapeutic Research Ltd.
Lambda offers senior professionals the opportunity to lead global clinical quality programs within a structured, regulatory-driven CRO environment. This role provides exposure to international inspections, sponsor audits, and high-impact clinical projects while contributing to global drug development quality standards.
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