Chief Quality Compliance & Regulatory Readiness

PAI Pharma; Greenville (SC); On-site; USD 180,000 - 240,000; Full time

Job summary

PAI Pharma is seeking a Sr. Director of Quality Compliance to lead governance, audits, inspections, escalation and risk management across the organization.

You will develop, implement and maintain cGMP compliance programs and ensure readiness for regulatory inspections worldwide, directing audits by FDA, DEA, Notified Bodies, and health authorities. The role demands strategic QA leadership, strong regulatory knowledge, and the ability to drive CAPAs, post-market surveillance, and continuous

Qualifications

• Bachelor’s degree in a science or engineering field related to pharma.
• 15+ years in QA/QC or risk management at senior leadership level in pharma.
• Proven ability to lead audits by FDA/DEA and Notified Bodies.
• Deep knowledge of GMP, QSRs, and global quality regulations.

Responsibilities

• Develop and implement quality compliance programs and policies.
• Conduct internal and external audits and manage Notified Bodies, FDA, and DEA audits.
• Oversee inspection readiness and regulatory inspections.
• Lead escalation to management for quality events and CAPA processes.
• Direct Post-Market Surveillance activities and ongoing quality system improvements.

Skills

Governance

Audits

Inspection readiness

CAPA leadership

Regulatory affairs

Quality leadership

Education

Bachelor’s degree in Pharmacy, Chemistry, Biology, Chemical Engineering, or relevant discipline

Tools

Quality management software

Microsoft Office

Job description

PAI Pharma is seeking a Sr. Director of Quality Compliance to lead governance, audits, inspections, escalation and risk management across the organization.

You will develop, implement and maintain cGMP compliance programs and ensure readiness for regulatory inspections worldwide, directing audits by FDA, DEA, Notified Bodies, and health authorities. The role demands strategic QA leadership, strong regulatory knowledge, and the ability to drive CAPAs, post-market surveillance, and continuous