We seek an experienced Quality Assurance Manager to enhance our Quality Assurance and Compliance function and support our expanding clinical trial supply operations in India and Bulgaria.

Location: Pune, India | In office | Depot-based
Role Scope: India and Bulgaria
Department: Quality Assurance and Compliance
Reports to: Head of Quality Assurance

What We’re Looking For
We are seeking a quality professional with proven hands-on expertise in:
· Clinical Trial Supplies & Depot Quality Operations
· Quality Management Systems (QMS / eQMS)
· Computer System Validation (CSV)
· GxP, cGMP, and cGDP compliance
· FDA 21 CFR Part 11, EU Annex 11, and Annex 13
· Cold-chain and temperature-controlled logistics
· Data integrity and computerized system compliance
· Regulatory, sponsor, and vendor audits
· Deviation, CAPA, and change control management
· Quality Risk Management (QRM)

Experience
· At least 5 years of QA experience in the pharmaceutical, biotech, CRO, or CDMO sector
· At least 2 years of direct experience in a clinical trial supplies depot environment,



including exposure to global distribution networks
· Hands-on experience with eQMS platforms such as Veeva Vault, TrackWise, MasterControl, or similar systems
· Practical experience in CSV within a GxP-regulated environments

Key responsibilities include:
· Managing and strengthening QMS and global and local compliance frameworks
· Driving eQMS, CSV, data integrity, and computerized system compliance
· Supporting regulatory inspections and global sponsor audits
· Overseeing quality aspects of clinical supply receipt, storage, release, quarantine, and distribution
· Ensuring quality oversight of cold-chain, ultra-low, and ambient storage operations
· Reviewing clinical supply, packaging, labeling, and cross-border shipping documentation
· Leading vendor qualification, audits, and Quality Risk Management
· Supporting harmonized quality practices across operations in India and Bulgaria

Qualification
Bachelor’s or Master

📌 Quality Assurance Manager (Pune)
🏢 Quantime World
📍 Pune