Job Title: Deputy Manager – Quality Assurance (Late Phase Clinical Research)
Job Category: Clinical Research / Quality Assurance / Regulatory Compliance
Job Type: Full-Time
Location: Ahmedabad, Gujarat, India
Req ID: 1270
CTC Range: INR 8,00,000 – 12,00,000 per annum
Company Overview
Lambda Therapeutic Research Ltd. is a global full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India. The organization provides comprehensive end-to-end clinical research services to innovator, biotechnology, and generic pharmaceutical companies worldwide.
With an established global presence across India, North America, and Europe, Lambda operates under robust regulatory frameworks to ensure data integrity, quality compliance, and excellence in clinical trial execution.
Role Overview
We are seeking an experienced Deputy Manager – Quality Assurance to lead and strengthen late-phase clinical QA operations. This role is responsible for overseeing internal and external audits, regulatory inspection readiness, quality trending, and mentoring QA teams to ensure full compliance with ICH-GCP, sponsor requirements, and global regulatory standards.
The position requires strong leadership, audit expertise, regulatory inspection experience, and in-depth knowledge of clinical trial documentation and quality systems.
Key Responsibilities
Conduct in-process, on-site, and remote audits to ensure clinical trial activities are performed, documented, analyzed, and reported in compliance with regulatory guidelines, organizational SOPs, and sponsor protocols.
Lead and mentor junior QA team members, providing training, supervision, and professional guidance.
Participate in internal project team meetings and drive quality-focused discussions and risk mitigation strategies.
Provide audit and inspection support for assigned projects, including preparation and conduct of regulatory inspections and sponsor audits.
Support Head-QA in managing regulatory inspections and sponsor system audits by organizing documentation, coordinating responses, and facilitating inspection logistics.
Track open audit observations, implement quality trending tools, and drive CAPA resolution to closure.
Perform and report system audits as per the annual audit plan to ensure compliance with SOPs, quality systems, and applicable regulations.
Conduct retrospective audits of study documentation including Informed Consent Forms (ICFs), project management plans, Investigational Medicinal Product (IMP) plans, Safety Management Plans (SMP), Clinical Study Reports (CSR), and associated documentation.
Required Experience
8 to 12 years of experience in Late Phase Quality Assurance within clinical research organizations, CROs, or pharmaceutical companies.
Proven experience in regulatory inspections, sponsor audits, and system audits.
Strong knowledge of ICH-GCP guidelines, global clinical regulations, and quality management systems.
Demonstrated leadership experience in mentoring and managing QA teams.
Expertise in audit reporting, CAPA management, quality trending, and inspection readiness.
Educational Qualification
M. Pharm (Master of Pharmacy) or equivalent qualification in pharmaceutical sciences.
Senior quality assurance professionals seeking leadership opportunities in global clinical research environments are encouraged to apply through ThePharmaDaily.com for confidential consideration.
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