Senior Manager, Quality Compliance

Eugia US LLC•East Windsor Township, NJ

14h•Onsite

About The Position

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.

Requirements

Strong understanding of FDA regulations, GxP requirements, quality systems, compliance programs, and inspection readiness activities.
Working knowledge of cGMP requirements and their application within a pharmaceutical environment.
Experience managing quality systems, deviations, investigations, CAPAs, audits, and change controls.
Experience overseeing outsourced Pharmacovigilance programs, including vendor governance, quality oversight, performance monitoring, audit management, and compliance activities.
Experience managing vendor compliance programs, audits, and quality agreements.
Familiarity with Safety Data Exchange Agreements (SDEAs) and third-party compliance oversight.
Familiarity with DSCSA requirements and pharmaceutical supply chain compliance.
Strong inspection readiness and audit management experience.
Demonstrated ability to identify compliance risks and implement effective mitigation strategies.
Demonstrated leadership and people management experience, including coaching, development, and performance management.
Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, Biology, or a related scientific discipline required.
Minimum of 10 years of relevant experience with demonstrated leadership responsibility within Quality Compliance, Quality Systems, or GxP compliance programs.
Experience supporting FDA inspections and regulatory audits.
Experience within a commercial pharmaceutical organization.
Experience supporting products manufactured by global or third-party manufacturing partners.
Previous experience in Quality Compliance, Internal Audit, Pharmacovigilance Quality, or Vendor Quality Management functions.
Proven experience managing employees and developing high-performing teams.
Demonstrated success leading cross-functional compliance initiatives and organizational improvement efforts.
Demonstrated experience overseeing outsourced Pharmacovigilance vendors, quality systems, audits, compliance metrics, and vendor governance programs required.

Nice To Haves

Advanced degree preferred.
Certified Quality Auditor (CQA) or other relevant quality/compliance certification preferred.

Responsibilities

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 compliance-related agreements.
Lead qualification, risk assessment, periodic review, and ongoing oversight of GxP vendors, contract service providers, and business partners.
Coordinate vendor audits and ensure timely remediation and closure of audit findings and CAPAs.
Monitor vendor performance metrics and ensure compliance with contractual, regulatory, and quality requirements.
Manage the GxP training compliance program and ensure personnel maintain required training and qualifications.
Monitor training effectiveness and ensure training records are maintained in accordance with company procedures.
Promote awareness of quality and compliance expectations throughout the organization.
Develop and execute internal audit programs covering Quality Systems, Pharmacovigilance oversight, DSCSA activities, and outsourced GxP processes.
Conduct compliance assessments, identify risks and gaps, and drive remediation activities.
Coordinate inspection readiness activities and support mock inspection programs.
Serve as a key Quality representative during FDA inspections, customer audits, and regulatory interactions.
Ensure audit observations and inspection findings are effectively addressed through appropriate CAPA plans.
Provide day-to-day leadership, coaching, and development for Quality Compliance personnel.
Establish departmental goals, priorities, and performance expectations aligned with organizational objectives.
Foster a culture of quality, accountability, continuous improvement, and inspection readiness.
Support employee development, succession planning, and talent growth within the Quality organization.
Partner cross-functionally to ensure alignment of compliance initiatives and business objectives.

Benefits

Medical Insurance: Choice of four Horizon Blue Cross Blue Shield of New Jersey plans — Premiums and coverage vary by plan.
Prescription Coverage: Included with medical insurance
Dental Insurance through Cigna
Vision Insurance through VSP
Life and AD&D Insurance: Company-paid Basic Life and AD&D with optional Supplemental coverage.
Disability Insurance: Voluntary Short-Term Disability and Long-Term Disability
Flexible Spending Accounts (FSAs) - Health and Dependent Care
Health Savings Account (HSA): Offered with HDHP enrollment
Voluntary Benefits: Identity Theft Protection, Critical Illness Insurance, Accident Insurance, and Legal Insurance
Employee Assistance Program (EAP): Confidential support services at no cost.
401(k) Retirement Plan: Pre-tax and Roth contribution options available, with company match; vesting applies.
Paid Time Off: Includes vacation, PTO, and company holidays (varies by role and tenure).
Employee Referral Program: $1,000 bonus for each qualified hire you refer.
annual bonus
discretionary incentives
role-based monthly allowances (e.g., cell phone or car allowance, where applicable)