QA Manager, Pharma — Compliance & Process Improvement

Piramal Pharma Limited; Sellersville (Bucks County); Presencial; USD 110.000 - 150.000; Jornada completa

Descripción de la vacante

Piramal Pharma Solutions' Sellersville, PA facility is seeking a qualified Quality Assurance Manager to lead QA operations, support commercial manufacturing, product disposition, investigations, quality systems, and regulatory compliance.

Partnering with Manufacturing, QC, Engineering, and Supply Chain, the role ensures ongoing cGMP adherence, regulatory readiness, and continuous improvement. Bachelor's in a scientific field and 8+ years GMP experience with 3+ years in supervision are required.

Formación

• Bachelor's degree in a scientific field is required.
• 8+ years of experience in GMP environments.
• 3+ years in supervision or management in QA.
• Experience supporting batch disposition, deviations, CAPAs, change controls.
• FDA inspections and customer audits preferred.

Responsabilidades

• Lead QA personnel in batch record review, disposition, investigations, and quality system activities.
• Review and disposition commercial product batches per procedures and regulations.
• Provide QA oversight for commercial manufacturing operations.
• Approve deviations, investigations, CAPAs, and change controls.
• Lead root cause investigations and implement CAPAs.
• Support product launches and process improvements.
• Participate in cross-functional teams focusing on quality and compliance.
• Monitor quality metrics and report to site leadership.
• Assist with FDA inspections and customer audits.
• Ensure cGMP compliance and data integrity across systems.

Conocimientos

cGMP knowledge

Leadership

Quality systems

Regulatory compliance

Root Cause Analysis

Cross-functional collaboration

Documentation

Project management

Communication

Data integrity

Educación

Bachelor's degree in Chemistry/Biology/Pharma Sciences/Engineering

GMP manufacturing experience

3+ years supervisory experience

Experience with FDA inspections

TrackWise/MasterControl/Veeva experience

Microsoft Office proficiency

Herramientas

TrackWise

MasterControl

Veeva

Microsoft Office

Descripción del empleo

Piramal Pharma Solutions' Sellersville, PA facility is seeking a qualified Quality Assurance Manager to lead QA operations, support commercial manufacturing, product disposition, investigations, quality systems, and regulatory compliance.

Partnering with Manufacturing, QC, Engineering, and Supply Chain, the role ensures ongoing cGMP adherence, regulatory readiness, and continuous improvement. Bachelor's in a scientific field and 8+ years GMP experience with 3+ years in supervision are required.