Principal Supplier Quality Specialist

Description

SHINE SPECT is seeking a Principal Supplier Quality Specialist to serve as a senior-level quality expert responsible for developing, enhancing, and executing the Supplier Quality Management (SQM) program to ensure robust controls, processes, and procedures across the global supply base. The Principal Supplier Quality Specialist ensures compliance with global regulatory requirements (FDA, EMA, ICH, ISO) and alignment with pharmaceutical industry best practices.

The Principal Supplier Quality Specialist partners closely with Procurement, Quality Assurance, Manufacturing, and External Manufacturing to ensure that materials, components, and services consistently meet quality, safety, and performance expectations.

• Supplier Qualification & Oversight:
  Serve as the technical lead, and continuously improve, the qualification program for suppliers, contractors, and service providers, ensuring comprehensive assessment of quality systems, technical capabilities, and compliance history.
• Conduct, coordinate, and/or oversee GMP and quality system audits as the lead auditor.
• Maintain the Approved Supplier List (ASL) and ensure supplier status information is current, accurate, and compliant.
• Perform risk assessments to determine appropriate levels of supplier oversight and monitoring.
• Supplier Performance Monitoring & Continuous Improvement:
  Establish and support monitoring of supplier performance metrics (KPIs/SLAs) related to quality, compliance, delivery, and responsiveness.
• Lead supplier performance reviews and drive collaborative continuous improvement initiatives.
• Analyze supplier performance data, identify trends, and implement risk mitigating actions.
• Quality Agreements & Supplier Change Management:
  Draft, negotiate, revise, and maintain Quality Agreements defining roles, responsibilities, and quality requirements.
• Manage the Supplier Change Notification process, ensuring timely internal evaluation, risk assessment, and implementation of controls.
• Collaborate cross functionally to assess regulatory and operational impact of supplier initiated changes.
• SCAR Management & Nonconformance Handling:
  Serve as the lead for the Supplier Corrective Action Request (SCAR) process, ensuring thorough investigations, root cause analysis, and effective CAPA implementation.
• Track SCAR performance and verify the long term effectiveness of corrective actions.
• Lead investigations associated with nonconforming materials and services, ensuring documentation meets internal and regulatory expectations.
• External Manufacturing Quality Support:
  Support External Manufacturing (ExM/CMO) operations by evaluating supplier issues that impact externally manufactured products.
• Review, assess, and approve supplier related deviations and CAPA, ensuring alignment with cGMP and internal requirements.
• Contribute technical expertise during technology transfers, onboarding of new CMOs, and raw material qualification projects.

• Ensure supplier related processes, documentation, and oversight practices comply with cGMP, ICH, and global regulatory requirements.
• Act as the subject matter expert during regulatory inspections and customer audits for supplier quality and the SQM program.
• Monitor industry trends and regulatory changes to ensure the SQM program remains current and best in class.
• Technical Leadership & Cross Functional Influence:
  Serve as a senior technical expert and thought leader in Supplier Quality Management.
• Lead cross-functional improvement initiatives and supplier-related quality governance activities.
• Influence organizational decisions using deep expertise in supplier risk, compliance, and quality systems.

• Serve as a senior technical expert and thought leader in Supplier Quality Management.
• Lead cross-functional improvement initiatives and supplier-related quality governance activities.
• Influence organizational decisions using deep expertise in supplier risk, compliance, and quality systems.

• Bachelor’s degree in Engineering, Life Sciences, Chemistry, Pharmacy, or a related field; advanced degree preferred.
• 10+…