Job Title: Deputy Manager – Quality Assurance (Late Phase)
Location: Ahmedabad, India
Company: Lambda Therapeutic Research Ltd.
CTC Range: INR 8,00,000 – 12,00,000 per annum
Experience Required: 8–12 years
Req ID: 1270
About Lambda Therapeutic Research
Lambda Therapeutic Research Ltd. is a globally recognized, full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India. With operational excellence across multiple geographies including Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK), and Warsaw (Poland), Lambda delivers comprehensive end-to-end clinical research services to global pharmaceutical innovators, biotech organizations, and generic drug manufacturers.
Job Summary
Lambda Therapeutic Research is seeking an experienced Deputy Manager – Quality Assurance (Late Phase) to strengthen its QA leadership team. This role is responsible for ensuring regulatory compliance, audit readiness, and quality oversight across late-phase clinical trials and associated systems. The position requires strong expertise in clinical quality audits, regulatory inspections, and team mentorship within a CRO environment.
Key Responsibilities
Conduct routine in-process, on-site, and off-site audits to ensure clinical trial activities, data recording, analysis, and reporting comply with applicable regulatory, organizational, and client requirements.
Verify compliance with protocols, SOPs, quality systems, contracts, and regulatory guidelines across assigned projects.
Act as a mentor and supervisor to junior QA team members, providing guidance, training, and performance oversight.
Participate in internal project and quality review meetings to facilitate informed quality discussions and risk mitigation.
Provide audit and inspection support during sponsor audits and regulatory inspections, including preparation, execution, and follow-up.
Support the Head of QA or designee in managing regulatory inspections, sponsor system audits, and responses to audit findings and queries.
Coordinate data collation, documentation readiness, and stakeholder communication for inspections and audits.
Perform quality trend analysis, track open issues, and drive corrective and preventive actions (CAPAs) to closure.
Execute and report system audits as per the annual audit calendar to ensure compliance with Lambda SOPs and regulatory standards.
Conduct retrospective audits of study-related documentation, including Informed Consent Forms, Project Management Plans, IMP documentation, Safety Management Plans, and Clinical Study Reports.
Required Experience
8 to 12 years of hands-on experience in Late Phase Clinical Quality Assurance within a CRO or pharmaceutical environment.
Proven expertise in regulatory inspections, sponsor audits, and system audits.
Strong understanding of global regulatory requirements (ICH-GCP, local and international regulations).
Demonstrated leadership experience in mentoring and managing QA teams.
Educational Qualification
Master of Pharmacy (M.Pharm) is mandatory.
Why Join Lambda Therapeutic Research
Opportunity to work with a globally established CRO on international clinical trials.
Leadership role with significant exposure to regulatory authorities and global sponsors.
Structured quality systems and strong compliance-driven culture.
Competitive compensation and long-term career growth opportunities.
Apply Now:
Qualified professionals may apply through ThePharmaDaily.com or submit their profile as per Lambda Therapeutic Research’s official recruitment process.
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