Manager Quality Systems & Compliance

Piramal

Sellersville, PA

Category Quality Assurance

Job Description

Piramal Pharma Solutions is seeking a Manager of Quality Systems & Compliance to ensure regulatory compliance for pharmaceutical drug products at PPL Healthcare LLC. This role involves maintaining and improving quality systems, providing training, overseeing audits, managing supplier relationships, and ensuring accurate data integrity. The ideal candidate will have deep knowledge of global regulatory requirements and excellent communication skills.

Requirements

In depth knowledge of global pharmaceutical regulations (e.g., FDA, EMA, PDMA, ANVISA, TGA, DEA)
In depth knowledge of Quality Management Systems and Quality Compliance for non-sterile pharmaceutical manufacturing
Experience with eQMS including DMS, LMS, and eBMR
Experience with audit, supplier management, and data integrity
Strong teamwork and communication skills
Bachelor degree or higher in a relevant scientific quality assurance/technical field

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Employer

Piramal