Global Quality Manager
2 weeks ago
The successful candidate will be responsible for overseeing quality aspects of all products distributed globally. They will serve as a liaison between the Contract Manufacturing Organization (CMO) and the company to ensure that operational business is in compliance with regulatory requirements, cGMP, Quality Technical Agreement, Piramal Quality Manual, and established Standard Operating Procedures (SOPs).
This position requires a high level of expertise in quality management, including quality systems in a GxP environment, release of finished products, routine audits of CMOs, follow-up for CAPA actions, and tracking to closure.
Responsibilities:- Provides quality and compliance oversight in QA/QC support at CMOs ensuring secure supply of high-quality products.
- Supports implementation of Quality Management System (QMS) requirements per regulatory and company requirements at CMOs.
- Performs release of finished products ensuring quick resolution of quality-related issues.
- Conducts routine audits of CMOs, follow-up for CAPA actions, and tracks to closure.
- Bachelor's degree required with focus in Pharmacy, Chemistry, or Microbiology; Master's degree preferred.
- Minimum 10-15 years of working experience in regulated pharmaceutical companies in GMP environment that use contract manufacturers.
- Hands-on experience of quality systems in a GxP environment.
- Direct experience with FDA; knowledge of EU GMP, MHRA, and other health authorities preferred.
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