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Assistant General Manager- Late Phase Qa

Lambda Therapeutic Research
Lambda Therapeutic Research
15+ years
INR 20,00,000 – 30,00,000
10 Oct. 7, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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