Manager – Quality Assurance (Late Phase)
Lambda Therapeutic Research Ltd. | Ahmedabad, India
Job Title: Manager – Quality Assurance
Req ID: 1271
Date Posted: 16 November 2025
Location: Ahmedabad, India
Company: Lambda Therapeutic Research Ltd.
Experience Required: 12–16 years (Late Phase Quality Assurance)
Education Required: M.Pharm
CTC Range: As per company standards (competitive; disclosed during selection)
About Lambda Therapeutic Research Ltd.
Lambda Therapeutic Research is a global full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India. With advanced facilities in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK), and Warsaw (Poland), Lambda delivers comprehensive end-to-end solutions to innovator pharma, biotech companies, and the global generics industry.
The organization is recognized for its expertise in clinical operations, regulatory compliance, medical writing, data sciences, QA, and pharmacovigilance. Lambda’s quality-driven approach, international reach, and robust scientific teams enable seamless execution of Phase I–IV trials across therapeutic domains.
Role Overview
The Manager – Quality Assurance will be responsible for ensuring that all clinical trial activities, documentation, data handling, and reporting meet global regulatory requirements, organizational SOPs, and client-specific expectations. The role involves routine audits, oversight of compliance activities, training of junior staff, and direct support during regulatory inspections.
This is a senior leadership position requiring strong experience in late-phase clinical trial quality assurance, regulatory preparedness, and quality systems management.
Key Responsibilities
Audit & Compliance Oversight
Conduct routine audits (in-process, on-site, and off-site) to verify compliance with regulatory requirements, internal SOPs, and client protocols.
Ensure trial activities are accurately documented, analyzed, and reported.
Perform and report system audits as per the annual audit calendar.
Regulatory & Sponsor Support
Support Head–QA/Designee during regulatory inspections, sponsor system audits, and audit readiness activities.
Coordinate data collation, responses to regulatory queries, and inspection preparation.
Provide expert guidance on compliance issues during audits and inspections.
Quality Systems Management
Contribute to quality trending, data analysis, and continuous improvement initiatives.
Track open quality issues and drive them towards timely resolution.
Review study-related raw data including ICFs, Safety Management Plans, IMP plans, release checklists, project management plans, and Clinical Study Reports.
Leadership & Mentorship
Mentor, supervise, and guide junior team members in QA practices, audit readiness, and documentation standards.
Lead quality discussions in internal project team meetings and ensure alignment with organizational quality goals.
Experience Requirements
12 to 16 years of experience in Late Phase Quality Assurance within clinical research, CRO, or pharma environments.
Strong understanding of global regulatory guidelines and clinical QA operations.
Educational Qualification
M.Pharm (Master of Pharmacy) or equivalent advanced degree in a life science discipline.
Salary / Compensation
CTC: Competitive and aligned with industry standards; final package shared during the interview process.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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