Quality Assurance Compliance Lead – GMP & Regulatory Expert

Piramal Critical Care, Inc.; Bethlehem (Northampton County); On-site; USD 90,000 - 130,000; Full time

Job summary

Piramal Critical Care, Inc. is seeking a Senior Quality Assurance Compliance Specialist to oversee daily QA activities, ensure GMP compliance, and manage documentation control.

The role involves review and approval of CoAs, regulatory readiness, and cross-functional collaboration to sustain quality across products. Ideal candidates have 5+ years of pharma QA experience, strong data analysis skills, and a proven ability to drive CAPAs, change controls, and audits within a global manufacturing

Qualifications

• Bachelor’s degree in a scientific, QA, or technical field.
• Minimum 5+ years of relevant experience in pharmaceutical QA/quality systems.
• Strong understanding of pharmaceutical cGMP, industry standards, and regulations.
• Cross-functional communication across different levels of the organization.
• Expertise in quality systems, validation, and GAMP requirements.

Responsibilities

• Review, approve, and disposition finished products; final CoA approvals.
• Coordinate investigations and CAPAs; manage change controls.
• Lead cross-functional deviation investigations and improvement projects.
• Support QA during regulatory audits and maintain document control.
• Maintain QA procedures and assist APR data collection and reporting.
• Manage supplier approvals and vendor-related activities.

Skills

Critical thinking

Regulatory decision making

Customer service

Professional communication

Attention to detail

Data analysis

Project management

Process improvement

Education

Bachelor’s degree in a scientific/QA/technical field

Tools

Microsoft Excel

eDMS (electronic Document Management System)

Validation tools / GxP software

Job description

Piramal Critical Care, Inc. is seeking a Senior Quality Assurance Compliance Specialist to oversee daily QA activities, ensure GMP compliance, and manage documentation control.

The role involves review and approval of CoAs, regulatory readiness, and cross-functional collaboration to sustain quality across products. Ideal candidates have 5+ years of pharma QA experience, strong data analysis skills, and a proven ability to drive CAPAs, change controls, and audits within a global manufacturing