Job Title: Assistant General Manager – Late Phase QA
Req ID: 1190
Date Posted: September 29, 2025
Location: Ahmedabad, India
Company: Lambda Therapeutic Research Ltd.
CTC Range: INR 20,00,000 – 30,00,000
Organizational Overview
Lambda Therapeutic Research is a global full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India, with facilities in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK), and Warsaw (Poland).
Key Highlights:
Provides end-to-end clinical research services for global innovator, biotech, and generic pharmaceutical companies
Focused on quality, compliance, and regulatory excellence
Department: Late Phase QA
Designation: Assistant General Manager
Education Required: M.Pharm / Ph.D.
Experience Required: 15+ years
Job Overview
The Assistant General Manager – Late Phase QA will ensure compliance, quality oversight, and audit readiness for late-phase clinical trials. The role involves reviewing processes, supporting inspections, conducting audits, and ensuring regulatory adherence across assigned projects.
Key Responsibilities
Prepare and compile data for Quality Review Board Meetings; prepare minutes of meetings and follow-up on action items
Review CAPA management effectiveness: identification, reporting, impact assessment, and implementation
Review study documents and issue QA statements and audit certificates per regulatory guidelines
Conduct audits (in-process, on-site, and off-site) to ensure trial activities and data comply with regulatory requirements, organizational policies, and client protocols
Perform system audits according to the annual audit calendar for ICH-GCP, SOPs, and quality systems compliance
Participate in internal project team meetings, facilitating quality discussions
Support Head-QA in preparing and reviewing SOPs for QA and other departments (Clinical Trial Management, Medical Affairs, Medical Imaging)
Provide audit and inspection support: advise project teams during preparation and conduct of audits/inspections
Support regulatory inspections and sponsor audits, arrange data, respond to queries, and coordinate inspection/audit activities
Conduct retrospective audits of study protocols and raw data as required
Regularly update Head-QA on compliance levels and issues
Required Competencies
Accountability
Strong Work Ethic
Initiative
Technical Knowledge
Organizational Culture Fit
Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Assam :
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Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
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Siliguri |Jharkhand :
Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Kerala :
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Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
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Rangpo |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy | Vellore | Yogyakarta |Uttar Pradesh :
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Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
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Dickinson |northeastern :
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Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Bavaria :
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Saarbrucken |Saxony Anhalt :
Halle |Schleswig Holstein :
Kiel |Belgium :
Wavre |BULGARIA :
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Copenhagen | Denmark |Europe :
France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Budapest |Istanbul :
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Basel | Zurich |Carlow :
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Brinny | Ringaskiddy |County Dublin :
Swords |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |Meath :
Dunboyne |Republic of Ireland :
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Ballydine |Ulster :
Donegal |China :
China | Quarry Bay |Hubei :
Wuhan |Liaoning :
Dalian |Republic of China :
Beijing |Shanghai Sai :
Shanghai Shi |Tokiyo :
Osaka | Tokyo |Zhejiang :
Hangzhou |Melbourne :
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Leiden |North Yorkshire :
Harrogate |Oxfordshire :
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Sheffield |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
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North York | Richmond Hill | Renfrew | Australia | Uxbridge | Mississauga |Quebec :
Montreal |Chile :
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Croatia |Zagreb :
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Cairo |Estonia :
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Tel Aviv | Be'Er Sheva | Yavne | Netanya | Kfar Saba |Italy :
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Warsaw |Remote :
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Bucharest |Makkah :
Riyadh | Rabigh | King Abdullah Economic City | Najran | Jeddah | Khulais |Nišava District :
Niš |Singapore :
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Ho Chi Minh City |