Pharmaceutical Manufacturing Plant

Department: Quality

Reports To: VP of Quality

Location: India (should be ready to move to US)

Employment Type: Full time

Position Summary

The Senior GM Quality is responsible for leading the site's Quality Assurance and Quality Control functions, ensuring all manufacturing operations comply with cGMP, FDA, and applicable state and international regulatory requirements. This role owns the quality management system (QMS) end-to-end from raw material release through finished product disposition and serves as the site's primary quality authority during regulatory inspections, client audits, and internal reviews. The ideal candidate brings deep sterile/aseptic manufacturing expertise and a track record of building or scaling quality systems in a growing pharmaceutical or compounding environment.

Key Responsibilities

Quality Systems & Compliance
- Own and continuously improve the site QMS, including deviations, CAPAs, change control, complaint handling, and product quality reviews.
- Ensure ongoing compliance with 21 CFR 210/211,



USP 795/797/800 (if applicable), EU GMP Annex 1, and other relevant guidance for sterile and non-sterile manufacturing.
- Maintain site readiness for FDA, state Board of Pharmacy, and third-party audits at all times.
- Serve as the site's primary point of contact and subject matter expert during regulatory inspections and client/partner audits.

Batch Release & Product Quality
- Own final disposition (release/reject) of raw materials, in-process product, and finished goods.
- Oversee investigation and root-cause analysis for deviations, OOS/OOT results, and product complaints; ensure timely, effective CAPA implementation.
- Review and approve batch records, master production records, and validation documentation.

Facility, Equipment & Environmental Monitoring
- Oversee environmental monitoring programs for cleanrooms and controlled areas, including viable/non-viable particulate monitoring.
- Own isolato

📌 Senior General Manager of Quality (Ahmedabad)
🏢 Medivant Healthcare
📍 Ahmedabad