Quality Compliance Leader – GxP & Inspection Readiness

Eugia US; New Jersey; On-site; USD 154,000 - 175,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life and AD&D Insurance

401(k) Retirement Plan

Paid Time Off

Job summary

Eugia US in East Windsor, NJ, seeks a Senior Manager, Quality Compliance to lead quality systems, PVG oversight, vendor governance, and DSCSA compliance. This role reports to the AVP, Regulatory Affairs & Quality Assurance and requires hands-on leadership in a fast-paced pharmaceutical setting.

The Senior Manager will guide training, audits, and inspection readiness while collaborating cross-functionally to strengthen overall quality and compliance across outsourced activities.

Qualifications

• Bachelor’s degree in a scientific discipline required; advanced degree preferred.
• Experience with FDA inspections and regulatory audits.
• Strong knowledge of quality systems, deviation/investigation/CAPA processes.
• Demonstrated leadership and cross-functional collaboration.

Responsibilities

• Lead and manage Quality Compliance programs to ensure FDA/GxP compliance.
• Oversee PVG quality oversight, vendor compliance, quality agreements, and training compliance.
• Ensure DSCSA compliance and supplier quality management.
• Coordinate internal audits, inspection readiness, and CAPA remediation.
• Provide leadership and development for Quality personnel; drive continuous improvement.

Skills

FDA regulations

GxP requirements

Quality systems

Inspection readiness

Pharmacovigilance oversight

Vendor governance

Leadership & people mgmt

Education

Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, Biology, or related scientific discipline

Advanced degree preferred

Job description

Eugia US in East Windsor, NJ, seeks a Senior Manager, Quality Compliance to lead quality systems, PVG oversight, vendor governance, and DSCSA compliance. This role reports to the AVP, Regulatory Affairs & Quality Assurance and requires hands-on leadership in a fast-paced pharmaceutical setting.

The Senior Manager will guide training, audits, and inspection readiness while collaborating cross-functionally to strengthen overall quality and compliance across outsourced activities.