Job Title: Deputy Manager – Quality Assurance
Company: Lambda Therapeutic Research Ltd.
Location: Ahmedabad, India
Req ID: 1270
Date Posted: Feb 10, 2026
Salary (CTC): ₹8,00,000 – ₹12,00,000 per year
Category: Quality Assurance / Clinical Research
Job Overview
The Deputy Manager – Quality Assurance will be responsible for ensuring that all clinical trial activities are conducted, documented, analyzed, and reported in compliance with regulatory requirements, organizational policies, and client protocols. The role involves performing audits, supporting regulatory inspections, mentoring team members, and maintaining quality systems across assigned projects.
Key Responsibilities
Conduct routine audits (in-process, on-site, and off-site) at different stages of clinical trials to ensure compliance with:
Regulatory requirements
Organizational policies and procedures
Client protocols and contractual obligations
Verify that trial-related activities, data recording, analysis, and reporting are accurate and compliant.
Perform system audits as per the annual audit calendar to ensure adherence to:
Lambda SOPs
Quality systems
Clinical protocols
Applicable regulatory requirements
Conduct retrospective audits of study-related documentation, including:
Informed Consent Forms (ICFs)
Project Management Plans
Investigational Medicinal Product (IMP) plans and release checklists
Safety Management Plans (SMP)
Clinical Study Reports
Participate in internal project meetings and facilitate discussions related to quality and compliance.
Provide audit and inspection support for assigned projects, including preparation and conduct of sponsor and regulatory audits.
Support Head – Quality Assurance (QA) or designee in handling:
Regulatory inspections
Sponsor system audits
Data preparation for regulatory reviews
Respond to regulatory or sponsor queries related to clinical trials and medical imaging activities.
Coordinate activities related to regulatory and sponsor inspections/audits.
Support quality analysis, issue tracking, and trending tools to monitor quality performance and drive resolution of open issues.
Mentor, supervise, and train junior team members to ensure skill development and adherence to quality standards.
Required Skills & Competencies
Strong knowledge of clinical trial quality assurance and regulatory compliance.
Experience in clinical audits, regulatory inspections, and sponsor audits.
Understanding of Good Clinical Practice (GCP), regulatory guidelines, and quality management systems.
Ability to conduct system audits, process audits, and documentation reviews.
Strong analytical, documentation, and problem-solving skills.
Leadership and mentoring abilities for training and guiding junior staff.
Excellent communication and coordination skills for interacting with cross-functional teams and sponsors.
Experience
8–12 years of experience in Late Phase Quality Assurance within clinical research, pharmaceutical companies, or CRO environments.
Educational Qualification
M.Pharm (Master of Pharmacy).
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