Senior Quality Compliance Lead - GxP, PV, DSCSA

Eugia US; East Windsor Township (NJ); On-site; USD 154,000 - 175,000; Full time

Benefits offered by this job

Medical Insurance: Four Horizon BCBS-N

Dental Insurance: Cigna

Vision Insurance: VSP

401(k) with company match

Paid Time Off

Job summary

Eugia is seeking a Senior Manager, Quality Compliance to lead the quality governance and ensure FDA, GxP, and PVG compliance across the organization. The role collaborates with cross-functional teams to drive continuous improvement and maintains inspection readiness.

The position is based in East Windsor, NJ, requires on-site work, and reports to the Associate Vice President, Regulatory Affairs & Quality Assurance. Relocation benefits are not provided.

Qualifications

• Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, Biology, or related field.
• Minimum of 10 years of leadership within Quality Compliance or GxP.
• Experience overseeing outsourced Pharmacovigilance and vendor quality programs.
• Strong FDA regulatory and inspection readiness knowledge.
• Certified Quality Auditor (CQA) preferred.

Responsibilities

• Lead Quality Compliance programs to ensure FDA and GxP compliance.
• Oversee Quality Systems, PVG oversight, vendor compliance, and training.
• Maintain inspection readiness and represent Quality during audits and regulatory inquiries.
• Develop CAPA plans and manage audit findings and remediation.
• Lead cross-functional quality initiatives and collaboration across functions.

Skills

FDA regulations

Quality Systems

GxP compliance

Audit management

Vendor governance

PVG oversight

Education

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

Advanced degree preferred

Certified Quality Auditor (CQA) preferred

Job description

Eugia is seeking a Senior Manager, Quality Compliance to lead the quality governance and ensure FDA, GxP, and PVG compliance across the organization. The role collaborates with cross-functional teams to drive continuous improvement and maintains inspection readiness.

The position is based in East Windsor, NJ, requires on-site work, and reports to the Associate Vice President, Regulatory Affairs & Quality Assurance. Relocation benefits are not provided.