QA Manager – GMP Compliance & Continuous Improvement

Piramal Pharma Ltd; Sellersville (Bucks County); On-site; USD 110,000 - 150,000; Full time

Job summary

Piramal Pharma Solutions' Sellersville, PA facility seeks a qualified Quality Assurance Manager to lead QA operations supporting commercial manufacturing, product disposition, investigations, quality systems, and regulatory compliance. This role provides oversight of QA personnel and partners with Manufacturing, QA Control, Engineering, and Supply Chain to ensure compliance with cGMP and regulatory standards.

The position supports continuous improvement, inspections, and site quality objectives.

Qualifications

• Bachelor's degree and GMP/regulatory knowledge.
• 8+ years in pharmaceutical GMP environments.
• 3+ years in QA leadership or supervision.
• Experience with FDA inspections preferred.
• Experience with batch disposition and QMS.

Responsibilities

• Lead QA personnel responsible for batch review and disposition.
• Review deviations, CAPAs, change controls, and QMS docs.
• Ensure timely product release in compliance with procedures.
• Support FDA inspections and customer audits.
• Drive continuous improvement and cross-functional collaboration.
• Mentor and develop QA staff.

Skills

Leadership

Quality systems

Regulatory compliance

cGMP

Root cause analysis

Team supervision

Documentation

Communication

Education

Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, Engineering, or related field

Tools

TrackWise

MasterControl

Veeva

Microsoft Office

Job description

Piramal Pharma Solutions' Sellersville, PA facility seeks a qualified Quality Assurance Manager to lead QA operations supporting commercial manufacturing, product disposition, investigations, quality systems, and regulatory compliance. This role provides oversight of QA personnel and partners with Manufacturing, QA Control, Engineering, and Supply Chain to ensure compliance with cGMP and regulatory standards.

The position supports continuous improvement, inspections, and site quality objectives.