Senior Manager, Quality Compliance

Division Overview

Eugia is US-based independent specialty pharmaceutical company focused on generic sterile injectables, oncology, hormones, and ophthalmic medicines. Eugia has best-in-class, dedicated manufacturing and R&D capabilities to meet customer needs as they emerge. We are committed to consistently providing our customers with high quality specialty medicines.

Eugia’s mission is to make the process of buying specialty pharmaceutical products an experience customers look forward to, and our vision is to become synonymous with excellent customer service and continuously improve upon this excellence by being transparent, responsive, and consistent. We are expanding Eugia’s capabilities to include the manufacture of highly complex injectables to answer that need.

Eugia is the partner of choice to deliver on the promise of generic specialty pharmaceuticals.

The Senior Manager, Quality Compliance is responsible for leading Eugia US Quality Compliance programs to ensure compliance with FDA regulations, GxP requirements, Pharmacovigilance (PVG) obligations, and DSCSA requirements. This role oversees Quality Systems, Pharmacovigilance quality oversight, vendor compliance, Quality Agreements, training compliance, internal audits, and inspection readiness activities. The position partners cross-functionally to drive continuous improvement, maintain effective oversight of outsourced activities and third-party service providers, and promote a culture of quality and compliance throughout the organization.

This position is based in East Windsor, NJ and reports directly to the Associate Vice President, Regulatory Affairs & Quality Assurance. The Senior Manager will provide leadership and development for Quality personnel while supporting the continued growth and effectiveness of the Quality Compliance function.

Please note
-This position is based in East Windsor, NJ. Applicants must be authorized to work in the United States, currently reside within commuting distance of the East Windsor office, and be able to work on-site. Relocation benefits are not provided.

• Lead and continuously improve Quality Systems to ensure compliance with FDA regulations, GxP requirements, company procedures, and industry best practices.
• Manage and maintain quality documentation, including SOPs, policies, procedures, controlled documents, and records.
• Oversee deviations, investigations, CAPAs, change controls, and associated effectiveness monitoring activities where applicable.
• Monitor and trend quality metrics, compliance performance indicators, and audit findings to identify risks and opportunities for continuous improvement.
• Drive quality and compliance initiatives that strengthen operational effectiveness and inspection readiness.

• Provide Quality oversight of outsourced Pharmacovigilance activities to ensure compliance with regulatory requirements, contractual obligations, and internal procedures.
• Monitor PVG quality metrics, compliance trends, deviations, investigations, CAPAs, and vendor performance where applicable.
• Support qualification, auditing, and ongoing oversight of Pharmacovigilance service providers and other GxP vendors.
• Ensure Safety Data Exchange Agreements (SDEAs), quality agreements, and PV-related quality documentation are maintained and compliant.
• Partner with Pharmacovigilance, Regulatory Affairs, and external vendors to address compliance risks and drive continuous improvement.
• Maintain inspection readiness for Pharmacovigilance-related activities and represent Quality during PVG audits, inspections, and regulatory inquiries.

• Support DSCSA compliance programs and supply chain security initiatives.
• Monitor evolving DSCSA requirements and support implementation of processes necessary to maintain compliance.
• Partner with Supply Chain, Distribution, and external partners to ensure compliance with applicable tracing, serialization, and regulatory requirements.

• Manage Quality Agreements, Technical Agreements, Safety Data Exchange Agreements (SDEAs), and other…