CDSA is a niche center of the Translational Health Science and Technology Institute (THSTI), established to facilitate the development of affordable healthcare products targeting public health diseases. It is the only public center in India dedicated to supporting cost-effective, high-quality, not-for-profit technology-based preclinical and clinical product development. CDSA collaborates with public sector institutions, SMEs, and research organizations to translate innovative technologies into medical products for public good.
Job Title: Quality Manager
Project: Effects of Extreme Heat on Maternal, Placental and Fetal Physiology, Lactation, and Newborn Health in India
Location: Gurugram Civil Hospital (GCH) and THSTI, Faridabad
Salary: Rs. 87,000 per month
Age Limit: Up to 45 years (Relaxations applicable as per government norms)
Essential Qualifications and Experience
- Option 1: MBBS, BDS, BVSc, BAMS, BHMS, BUMS, BSMS, BNYS, B.Sc. Nursing, BPT, B.Pharm with 4 years of clinical trial monitoring or clinical site coordination & management experience.
- Option 2: Graduation in Life Sciences/Biomedical Sciences/Public Health with 6 years of relevant experience.
- Option 3: Post-Graduation or Ph.D. in Life Sciences/Biomedical Sciences/Pharmacy/Public Health with 4 years of relevant experience.
- Must possess a valid Good Clinical Practice (GCP) certificate.
Desirable: 2 years of experience in Quality Control and Quality Assurance in clinical research.
Job Description
As a Quality Manager at CDSA, you will:
- Oversee quality management processes and ensure compliance with GCP guidelines and regulatory requirements.
- Conduct regular site monitoring visits from initiation to closeout.
- Lead internal quality improvements and CAPA (Corrective and Preventive Actions).
- Identify non-conformances and recommend corrective measures using risk-based methodologies.
- Train study staff on good clinical and documentation practices.
- Manage trial supplies and ensure proper documentation.
- Develop SOPs, quality monitoring plans, and checklists for clinical and laboratory activities.
- Coordinate expert monitoring visits and audits.
- Collaborate with clinical, data management, and laboratory teams to ensure project quality and timelines.
- Travel frequently to study sites as required.
Key Skills Required
- Strong knowledge of GCP, GLP, clinical trial monitoring, and regulatory guidelines.
- Ability to develop and implement monitoring plans and SOPs.
- Excellent communication, leadership, and team-building skills.
- Proficiency in MS Office (Word, Excel, Email).
- Problem-solving and risk assessment capabilities.
- Ethical mindset and commitment to quality standards.
How to Apply
Interested candidates who meet the eligibility criteria are invited to walk-in for a written test/skill test/interview on:
Date: 16 September 2025
Time: 9:00 AM onwards
Venue: THSTI, NCR Biotech Science Cluster, 3rd Milestone, Faridabad-Gurugram Expressway, Faridabad – 121001
