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.
Summary of Essential Functions: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.
Specific Duties, Activities, and Responsibilities:- 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 agreements, risk assessments, SOPs, audit documentation, and supplier quality records.
- Support internal audits, customer audits, and regulatory inspections by serving as a supplier quality subject matter resource and providing accurate, inspection-ready documentation.
- Contribute to continuous improvement of the Supplier Quality Management program, including procedure updates, process standardization, training materials, templates, and risk-based oversight tools.
- Maintain current knowledge of applicable GMP regulations, regulatory guidance, industry expectations, and internal quality standards relevant to supplier qualification and oversight.
- Perform other quality-related duties as assigned to support site compliance, operational readiness, and business continuity.
Required Qualifications:- Bachelor's degree in life sciences, chemistry, biology, microbiology, engineering, pharmaceutical sciences, or a related technical discipline required; equivalent combination of education and relevant GMP experience may be considered.
- Minimum of 2-5 years of experience in Quality Assurance, Quality Control, Supplier Quality, Manufacturing Quality, Technical Operations, or a related function within a GMP-regulated pharmaceutical, biotechnology, medical device, or contract manufacturing/testing environment.
- Experience supporting supplier qualification, supplier audits, quality agreements, risk assessments, CAPA, deviation management, change control, document control, or quality system records preferred.
- Experience supporting regulatory inspections, client audits, internal audits, or supplier audits is preferred.
Preferred Qualifications:- Working knowledge of current GMP expectations and quality system principles applicable to pharmaceutical manufacturing and supplier oversight.
- Understanding of supplier qualification, supplier risk classification, audit lifecycle management, approved supplier list maintenance, quality agreements, and supplier performance monitoring.
- Knowledge of deviation, CAPA, change control, complaint, out-of-specification/out-of-trend, and risk management processes.
- Ability to review technical and quality documents critically, identify gaps, and communicate clear, risk-based quality expectations.
- Strong technical writing skills, attention to detail, and ability to prepare clear, accurate, and inspection-ready documentation.
- Effective communication, collaboration, and follow-up skills with internal stakeholders and external suppliers.
- Ability to manage multiple priorities, meet deadlines, and escalate issues appropriately in a fast-paced GMP environment.
- Proficiency with Microsoft Office applications; experience with eQMS, electronic document management systems, ERP systems, or supplier management platforms preferred.
- Professional certification such as ASQ CQA, CQA, CQIA, CQE, or equivalent quality certification is preferred but not required.
Physical Requirements:- Ability to sit, stand, walk, and use a computer for extended periods.
- Ability to review records, reports, and electronic quality system data with close attention to detail.
- Ability to occasionally access manufacturing, warehouse, laboratory, utility, or controlled areas in accordance with site gowning and safety requirements.
- Ability to travel occasionally to supplier locations for audits or business meetings, as required.
Salary Range:
$85,000 - $100,000 DOE
How to ApplyReady to advance your career in pharmaceutical development? Apply now through the Ardena Careers website at careers.ardena.com.
Department Quality Control Locations Somerset (New Jersey, US)
