Quality Compliance Leader — QA, PVG & Inspections

Acrotech Biopharma inc.; East Windsor Township (NJ); On-site; USD 154,000 - 175,000; Full time

Job summary

Eugia US is seeking a Senior Manager, Quality Compliance to lead quality programs including PVG, DSCSA, and vendor governance from East Windsor, NJ. The role reports to the Associate Vice President, Regulatory Affairs & Quality Assurance.

The position requires a strong background in FDA regulations, GxP, quality systems, and inspection readiness, with a focus on cross-functional leadership and continuous improvement.

Qualifications

• Strong knowledge of FDA regulations, GxP, quality systems, and inspection readiness.
• Experience overseeing outsourced PVG programs and vendor governance.
• Experience managing quality agreements, audits, and CAPAs.
• Demonstrated leadership and cross-functional collaboration.
• Experience supporting FDA inspections and regulatory audits.

Responsibilities

• Lead Quality Compliance programs to ensure regulatory and company standards.
• Oversee Quality Systems, deviations, CAPAs, and change controls.
• Maintain inspection readiness and support FDA inspections.
• Partner with PVG, Regulatory Affairs, and vendors to mitigate risks.

Skills

FDA regulations

GxP knowledge

Quality systems

Inspection readiness

Vendor governance

Cross-functional leadership

Education

Bachelor's degree in Pharmacy or Life Sciences

Advanced degree preferred

Certified Quality Auditor (CQA) preferred

Job description

Eugia US is seeking a Senior Manager, Quality Compliance to lead quality programs including PVG, DSCSA, and vendor governance from East Windsor, NJ. The role reports to the Associate Vice President, Regulatory Affairs & Quality Assurance.

The position requires a strong background in FDA regulations, GxP, quality systems, and inspection readiness, with a focus on cross-functional leadership and continuous improvement.