Senior QA Manager – cGMP & Compliance Leader

PPL Healthcare LLC; Sellersville (Bucks County); On-site; USD 120,000 - 170,000; Full time

Job summary

Piramal Pharma Solutions, located in Sellersville, Pennsylvania, is seeking a qualified Quality Assurance Manager to lead QA operations supporting commercial manufacturing, product disposition, investigations, quality systems, and regulatory compliance.

The role collaborates with Manufacturing, Quality Control, Engineering, Supply Chain, and other site functions to ensure cGMP compliance and readiness for regulatory inspections, driving continuous improvement and site quality objectives.

Qualifications

• Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, Engineering, or related scientific discipline.
• Minimum of 8 years of experience in pharmaceutical, biotechnology, or other GMP-regulated manufacturing environments.
• Minimum of 3 years of supervisory or management experience within a Quality Assurance organization.
• Experience supporting batch disposition, deviations, investigations, CAPAs, change controls, and quality systems.
• Experience with FDA inspections and customer audits preferred.

Responsibilities

• Manage QA personnel responsible for batch record review and quality system activities.
• Ensure timely review and disposition of commercial product batches in accordance with procedures and regulatory requirements.
• Provide quality oversight and support for commercial manufacturing operations.
• Review and approve deviations, investigations, CAPAs, change controls, and other quality system documentation.
• Lead root cause investigations and ensure effective corrective and preventive actions are implemented.
• Support product launches, process improvements, and continuous improvement initiatives.
• Participate in cross-functional teams focused on product quality, compliance, and operational excellence.
• Monitor, trend, and communicate quality metrics to site leadership.
• Support FDA inspections, customer audits, and regulatory agency interactions.
• Ensure departmental compliance with cGMP requirements and company quality systems.
• Recruit, train, coach, develop, and evaluate Quality Assurance personnel.
• Manage departmental objectives and ensure alignment with site and corporate goals.
• Serve as a technical resource and subject matter expert for quality-related matters.
• Perform other duties as assigned.

Skills

QA leadership

Regulatory knowledge

cGMP expertise

Quality systems

Cross-functional collaboration

Education

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

Tools

TrackWise

MasterControl

Veeva

Job description

Piramal Pharma Solutions, located in Sellersville, Pennsylvania, is seeking a qualified Quality Assurance Manager to lead QA operations supporting commercial manufacturing, product disposition, investigations, quality systems, and regulatory compliance.

The role collaborates with Manufacturing, Quality Control, Engineering, Supply Chain, and other site functions to ensure cGMP compliance and readiness for regulatory inspections, driving continuous improvement and site quality objectives.