Global Supplier Quality System Professional

Kindeva Drug Delivery•Woodbury, MN

1d•$104,000 - $137,000•Onsite

About The Position

Global Supplier Quality Professional is responsible for leading and executing the global Supplier Change Management, Vendor Change Notification (VCN), and Supplier Quality Agreement (SQA) programs, ensuring that supplier-initiated changes to materials, components, processes, facilities, equipment, sourcing, quality systems, and contractual quality requirements are identified, assessed, approved, communicated, and implemented in compliance with regulatory, quality, and business requirements. This role serves as the primary liaison between suppliers and cross-functional stakeholders, including Quality, R&D, Operations, Legal, and Procurement, to evaluate the impact of supplier changes on product quality, patient safety, regulatory compliance, and supply continuity. The position drives robust change notification and supplier quality governance processes by establishing, negotiating, implementing, and maintaining Supplier Quality Agreements that clearly define quality responsibilities, change notification requirements, compliance expectations, and escalation pathways between the organization and its suppliers. The role monitors supplier compliance with change notification requirements and Supplier Quality Agreements through performance metrics.

Requirements

Bachelor’s degree in life sciences, engineering, or related field required; advanced degree preferred.
8+ years of progressive quality experience in Supplier Quality, Quality Engineering, or Quality Systems in a regulated industry
Demonstrated experience working with global suppliers and cross-regional teams
Strong knowledge of Quality Management Systems (QMS) and supplier controls
Experience with regulatory standards such as ISO 13485, ISO 9001, FDA 21 CFR Part 820, and/or GMP requirements
Proficiency in quality tools and methodologies (e.g., FMEA, SPC, process validation, statistical analysis)
Experience managing vendor change notifications, supplier audits, CAPA systems, and change control processes
Advanced problem-solving and root cause analysis capabilities
Strong project management skills with ability to manage multiple initiatives globally
Excellent communication and stakeholder management skills across technical and non-technical audiences
Ability to influence without authority and drive accountability across a global supply base
High level of analytical capability with experience interpreting supplier performance data

Nice To Haves

Six Sigma Green/Black Belt
Experience in medical device, pharmaceutical, or other highly regulated industries
Experience working with Supply Chain and/or Procurement

Responsibilities

Lead and execute the global Vendor Change Notification (VCN), Supplier Change Management, and Supplier Quality Agreement (SQA) programs.
Ensure supplier-initiated changes (e.g., material, component, process, equipment, facility, subcontractor, test method, and quality system changes) are identified, reviewed, approved, and implemented in accordance with Quality Management System (QMS) requirements, Supplier Quality Agreements, and regulatory expectations.
Develop, negotiate, implement, maintain, and periodically review Supplier Quality Agreements to ensure clear definition of quality responsibilities, change notification requirements, regulatory compliance obligations, escalation processes, record retention requirements, and supplier performance expectations.
Maintain and continuously improve supplier change management and Supplier Quality Agreement procedures, policies, templates, and governance processes to ensure consistency, compliance, and effectiveness across the supplier network.
Establish supplier change notification requirements, risk classifications, approval workflows, and escalation pathways, ensuring alignment with Supplier Quality Agreement commitments and business requirements.
Monitor supplier compliance with contractual quality obligations and change notification requirements, ensuring timely communication and adherence to agreed quality standards.
Evaluate supplier change notifications for potential impact to product quality, patient safety, regulatory compliance, manufacturing processes, and supply continuity.
Coordinate cross-functional reviews involving Quality, R&D, Engineering, Operations, and Procurement to assess, approve, and implement supplier changes.
Review supplier changes against Supplier Quality Agreement requirements to ensure all notification, approval, and compliance obligations are fulfilled.
Maintain supplier change records and ensure traceability throughout the change lifecycle.
Serve as the business owner and subject matter expert for the Supplier Quality Agreement program.
Partner with Procurement, Legal, Regulatory Affairs, and Quality teams to negotiate, execute, renew, and maintain Supplier Quality Agreements across the supplier lifecycle.
Ensure Supplier Quality Agreements are established for applicable suppliers based on risk, regulatory requirements, and business needs.
Conduct periodic reviews of Supplier Quality Agreements to ensure alignment with current regulatory requirements, quality system expectations, organizational policies, and supplier capabilities.
Drive resolution of quality agreement gaps, deviations from contractual requirements, and compliance concerns through collaboration with suppliers and internal stakeholders.
Maintain Supplier Quality Agreement documentation, records, metrics, and governance processes to support audit readiness and inspection preparedness.
Monitor supplier compliance with change notification requirements and Supplier Quality Agreement obligations, including timeliness, completeness, and effectiveness.
Track key performance indicators (KPIs) related to supplier change management, and quality agreement compliance.
Analyze trends in supplier changes, audit observations, quality events, and contractual compliance metrics to identify emerging risks and improvement opportunities.
Drive continuous improvement initiatives that enhance supplier quality governance and regulatory compliance.
Ensure supplier change management and Supplier Quality Agreement activities comply with applicable regulatory and quality requirements, including ISO 13485, FDA 21 CFR Part 820/QMSR, GMP, and other relevant standards.
Support internal audits, external audits, customer audits, and regulatory inspections related quality agreements, and change management processes.
Maintain inspection-ready documentation, records, risk assessments, quality agreements, and audit evidence supporting supplier oversight activities.
Monitor evolving regulatory requirements and implement updates to supplier governance processes and quality agreements as needed.
Serve as the primary Supplier Quality representative for supplier change management and Supplier Quality Agreement activities across global functions.
Collaborate with R&D, Engineering, Regulatory Affairs, Operations, Manufacturing, Procurement, and Legal to evaluate supplier risks, change impacts, and contractual quality requirements.
Facilitate cross-functional decision-making and risk assessments to support timely implementation of supplier changes and quality agreement requirements.
Build strong partnerships with suppliers to ensure proactive communication, effective governance, and management of quality and compliance risks.
Lead or contribute to global initiatives focused on harmonizing supplier change management and Supplier Quality Agreement programs.
Influence supplier and internal stakeholder decisions through risk-based assessments, quality data, contractual requirements, and compliance-focused recommendations.
Provide guidance, training, and subject matter expertise on supplier change management, and Supplier Quality Agreement requirements across the organization.
Plan, conduct, and lead supplier audits (qualification, surveillance, and for-cause audits).
Assess supplier adherence to contractual change notification requirements, Supplier Quality Agreements, and applicable regulatory standards.
Identify gaps in supplier quality systems and drive timely remediation through audit findings, corrective actions, and continuous improvement initiatives.
Support supplier qualification and ongoing oversight activities through risk-based audit planning and execution.
Verify supplier compliance with quality agreement commitments during audits and supplier performance reviews.