Senior Quality Specialist, Supplier Quality Management

About Ardena

Ardena is a global Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) specializing in precision medicine development. Ardena supports pharmaceutical and biotechnology companies in bringing innovative, complex molecules from discovery to market.

Ardena is a global Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) specializing in precision medicine development. Ardena supports pharmaceutical and biotechnology companies in bringing innovative, complex molecules from discovery to market.

The Ardena Group operates from five sites across Europe and the United States, employing more than 750 professionals. Ardena European sites are located in Oss and Assen (the Netherlands), Ghent (Belgium), and Pamplona (Spain). Ardena US facility is based in Somerset, New Jersey.

Ardena provides integrated services spanning drug substance development, drug product formulation, GMP manufacturing, bioanalytical services, clinical logistics, fill and finish, and CMC regulatory support.

Ardena is hiring a Senior Quality Specialist, Supplier Quality Management to join the Quality team at our Somerset, NJ site. This role supports pharmaceutical development and manufacturing activities within a GMP-regulated environment.

The Senior Quality Specialist, Supplier Quality Management supports the development, implementation, and maintenance of the site Supplier Quality Management program for a GMP manufacturing environment.

The role ensures that suppliers of materials, components, services, contract testing, calibration, maintenance, and other GMP-relevant activities are appropriately qualified, monitored, and maintained in accordance with applicable procedures, quality agreements, regulatory expectations, and business needs.

The position partners with Quality Assurance, Quality Control, Manufacturing, Supply Chan, Product Development, Regulatory Compliance, and external suppliers to support supplier onboarding, risk assessments, audits, quality event management, change notifications, performance monitoring, and continuous improvement.

• Support initial supplier qualification, periodic requalification, and ongoing supplier monitoring activities in accordance with approved procedures and risk-based supplier management requirements.
• Maintain supplier records, approved supplier lists, supplier files, qualification documentation, quality agreements, questionnaires, audit reports, and related supplier quality documentation.
• Perform or support supplier risk assessments based on material or service criticality, supplier history, compliance status, quality performance, and potential impact to product quality, patient safety, data integrity, and GMP operations.
• Coordinate supplier onboarding activities with Supply Chain, Quality, Manufacturing, Laboratory Operations, Product Development, and other stakeholders to ensure suppliers are approved prior to GMP use.
• Schedule, prepare for, conduct, support, or follow up on supplier audits, including audit agenda preparation, audit report drafting, observation classification, response review, and CAPA follow-up through closure.
• Review supplier corrective and preventive action responses for adequacy, timeliness, root cause rationale, impact assessment, and effectiveness of proposed actions.
• Support investigation and resolution of supplier-related deviations, nonconformances, complaints, material issues, out-of-specification or out-of-trend events, and other supplier quality concerns.
• Assess supplier change notifications for potential impact to materials, services, specifications, validated processes, regulatory filings, quality agreements, and site procedures.
• Partner with internal stakeholders to ensure supplier quality issues are escalated appropriately and documented through the applicable quality system, including deviation, CAPA, change control, complaint, and risk management processes.
• Monitor supplier quality performance indicators, including audit schedule adherence, quality event trends, response timeliness, CAPA closure, and supplier status changes.
• Prepare supplier quality metrics, summaries, and updates for Quality Management Review, supplier governance meetings, audits, inspections, and management briefings.
• Review and approve supplier-related GMP documentation, as assigned, including qualification packages, quality…