Job Title: Deputy Manager – Quality Assurance (Late Phase Clinical Trials)
Req ID: 1270
Location: Ahmedabad, India
Company: Lambda Therapeutic Research Ltd.
CTC Range: INR 800,000 – 1,200,000
Organizational Overview:
Lambda Therapeutic Research Ltd. is a global full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India. With strategically located facilities in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK), and Warsaw (Poland), we provide end-to-end clinical research services to pharmaceutical innovators, biotech companies, and generic drug industries worldwide.
Position Overview:
We are seeking an experienced Deputy Manager – Quality Assurance (Late Phase Clinical Trials) to ensure compliance with regulatory standards, organizational policies, and client requirements. The role involves conducting audits, supporting regulatory inspections, mentoring QA teams, and driving quality improvement across clinical trials and associated processes.
Key Responsibilities:
Conduct audits (in-process, on-site, and off-site) to verify that trial-related activities, data recording, analysis, and reporting comply with regulatory requirements, organizational SOPs, and client protocols.
Serve as a mentor and supervisor to junior QA team members, providing guidance, training, and support.
Participate in key internal project meetings, facilitating quality discussions and providing recommendations.
Provide audit and inspection support for assigned projects, including advising project teams during audit preparation and execution.
Support Head-QA/Designee in managing regulatory inspections and sponsor system audits, including data arrangement, responding to queries, and coordinating inspections.
Assist in quality analysis, tracking open issues, and driving resolution using trending and monitoring tools.
Perform and report system audits as per the annual audit calendar, ensuring compliance with SOPs, quality systems, protocols, and regulatory requirements.
Conduct retrospective audits of study-related raw data, including Informed Consent Forms, Project Management Plans, IMP plans, IMP release checklists, Safety Management Plans, and Clinical Study Reports.
Experience Required:
8 to 12 years of experience in Late Phase Quality Assurance within clinical research organizations or pharmaceutical/biotech industry.
Educational Qualification:
Master’s in Pharmacy (M.Pharm) or equivalent.
Why Join Lambda Therapeutic Research:
Opportunity to work with a globally recognized CRO with multi-country operations.
Exposure to late-phase clinical trials, QA audits, regulatory inspections, and sponsor interactions.
Leadership and mentorship opportunities in a collaborative, high-performance QA environment.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak | Shivalik |Andra Pradesh :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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