Senior Global Supplier Quality Professional II

Kindeva Drug Delivery•Woodbury, MN

1d•$104,000 - $137,800•Onsite

About The Position

Global Supplier Quality Systems Professional II is responsible for leading and executing global supplier and material governance programs that support material qualification and material lifecycle management across the supply chain. This role ensures that new suppliers, materials, and components are effectively assessed, qualified, approved, and integrated in compliance with quality, regulatory, and business requirements. The position serves as a key liaison between suppliers and cross-functional stakeholders, including Quality, Supply Chain, Procurement, R&D, Regulatory Affairs, Operations, and Manufacturing, to facilitate supplier selection, material onboarding, risk assessment, qualification activities, and ongoing supplier performance management. The role drives robust qualification standards, material approval workflows, and governance frameworks that support product quality, regulatory compliance, patient safety, and uninterrupted supply. Additionally, the Global Supplier Quality Systems Professional supports supplier change management and quality agreement programs to ensure supplier-initiated changes, sourcing transitions, material updates, process modifications, and quality system changes are appropriately evaluated, communicated, and implemented. The position supports strategic supply chain initiatives through effective supplier partnerships, risk mitigation, performance monitoring, and continuous improvement activities that strengthen supplier reliability and operational excellence across the global network. Operating within a regulated environment, the role ensures supplier change management and quality agreement activities align with applicable global standards and regulations (e.g., ISO 13485, FDA 21 CFR Part 820, and other applicable regional requirements). Responsibilities include oversight of supplier change notifications throughout the supplier lifecycle; ensuring supplier adherence to contractual quality and notification obligations; facilitating timely supplier communications and documentation updates; and implementing appropriate controls to mitigate quality, regulatory, business continuity, and supply risks. 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.
8+ years of progressive quality experience in Supplier Quality, Materials Quality, or Quality Systems in a regulated industry.
Experience in medical device, pharmaceutical, or other highly regulated industries.
Demonstrated experience working with global suppliers and cross-regional teams.
Strong knowledge of Quality Management Systems (QMS), materials 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

Responsibilities

Lead global quality material onboarding and lifecycle management activities, ensuring materials are appropriately qualified, risk assessed, and aligned with supplier qualification requirements to support a compliant and resilient supply chain.
Support 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 and change notification requirements.
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.
Monitor supplier compliance with contractual quality obligations and change notification requirements, ensuring timely communication and adherence to agreed quality standards.
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.