QA Manager, Pharmaceutical Quality & Compliance

Piramal Pharma Limited; Pennsylvania; On-site; USD 120,000 - 180,000; Full time

Job summary

Piramal Pharma Solutions' manufacturing facility in Sellersville, Pennsylvania, seeks a qualified Quality Assurance Manager to lead QA operations supporting commercial manufacturing, product disposition, investigations and quality systems.

The role partners with Manufacturing, QC, Engineering, Supply Chain, and site functions to ensure regulatory compliance and company quality standards. Strong leadership and QA expertise are essential.

Qualifications

• Bachelor's degree required in Chemistry, Biology, Pharmaceutical Sciences, Engineering, or related field.
• Minimum of 8 years in GMP-regulated manufacturing environments.
• Minimum of 3 years of supervisory experience within a Quality Assurance organization.
• Experience with batch disposition, deviations, investigations, CAPAs, change controls, and quality systems.
• Experience supporting commercial manufacturing operations and FDA inspections.

Responsibilities

• Manage and supervise QA personnel responsible for batch record review, product disposition, investigations, and quality system activities.
• Provide quality oversight 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 actions.
• Support product launches, process improvements and continuous improvement initiatives.
• Participate in cross-functional teams focused on quality, compliance, and operational excellence.
• Monitor, trend, and communicate quality metrics to site leadership.
• Support FDA inspections and customer audits.

Skills

Leadership

Root cause analysis

Communication

Project management

Risk assessment

Continuous improvement

Cross-functional collaboration

Organizational skills

Education

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

Tools

TrackWise

MasterControl

Veeva

Job description

Piramal Pharma Solutions' manufacturing facility in Sellersville, Pennsylvania, seeks a qualified Quality Assurance Manager to lead QA operations supporting commercial manufacturing, product disposition, investigations and quality systems.

The role partners with Manufacturing, QC, Engineering, Supply Chain, and site functions to ensure regulatory compliance and company quality standards. Strong leadership and QA expertise are essential.