Senior QA & Regulatory Compliance Leader

Piramal Pharma Limited; Bethlehem (Northampton County); On-site; USD 90,000 - 130,000; Full time

Job summary

Piramal Critical Care in Bethlehem seeks a Senior Quality Assurance Compliance Specialist to oversee daily QA activities, ensuring GMP and regulatory compliance. You will review records, manage document control, CAPA processes, and support audits to uphold product integrity.

The role requires strong cGMP knowledge, cross-functional collaboration, and proficiency with quality systems and validation practices.

Qualifications

• Bachelor’s degree in a scientific, quality assurance, or technical field.
• Minimum 5+ years of relevant experience.
• Strong understanding of pharmaceutical cGMP, industry standards, and regulations.
• Strong cross-functional communication across different levels of the organization.
• Expertise in Quality systems and tools.
• Proficiency in Microsoft Outlook, Excel, Word, and other web-based systems.
• Strong understanding of computer system validation and GAMP requirements.

Responsibilities

• Review, approve, and disposition finished products and provide final Certificate of Analysis (CoA) approval.
• Facilitate client project management to ensure quality deliverables are completed on time and in full.
• Coordinate investigation and closure of non-conformances, ensuring CAPA and change controls are initiated and completed.
• Lead or participate in cross-functional deviation investigations and improvement projects.
• Review and approve laboratory investigations, ensuring root cause identification.
• Support QA team members and assist in departmental training.
• Provide support during regulatory audits.
• Maintain and revise QA procedures.
• Oversee and manage document control systems and change controls.

Skills

Critical thinking

Customer service

Communication

Detail-oriented

Organizational skills

Data analysis

Project management

Education

Bachelor’s degree in scientific/QA/technical field

Tools

Microsoft Outlook

Excel

Word

eDMS

Job description

Piramal Critical Care in Bethlehem seeks a Senior Quality Assurance Compliance Specialist to oversee daily QA activities, ensuring GMP and regulatory compliance. You will review records, manage document control, CAPA processes, and support audits to uphold product integrity.

The role requires strong cGMP knowledge, cross-functional collaboration, and proficiency with quality systems and validation practices.