[Hiring] Senior Global Supplier Quality Professional II @Kindeva Drug Delivery

Role Description

The Senior Global Supplier Quality Professional II is responsible for executing global supplier quality strategies to ensure that externally sourced materials, components, and services consistently meet quality, regulatory, and business requirements. This role acts as a key interface between internal cross-functional teams (Quality, R&D, Operations, Procurement) and suppliers worldwide, driving supplier performance, compliance, and continuous improvement.

The position operates within a regulated environment and supports global quality systems aligned to applicable standards (e.g., ISO 13485, FDA 21 CFR Part 820), ensuring end-to-end supplier lifecycle management—from qualification through ongoing monitoring and development.

Key Responsibilities

• Execution of global supplier quality strategies, policies, and procedures across regions and business units.
• Ensure alignment of supplier quality processes with Quality Management System (QMS) requirements and regulatory standards.
• Partner with Global Supply Chain and Procurement to establish supplier segmentation, risk classification, and oversight models.
• Assist in supplier selection, qualification, onboarding, and inclusion in Approved Supplier Lists (ASL).
• Conduct and/or lead supplier audits (initial, surveillance, for-cause) to assess compliance with quality and regulatory standards.
• Assist in maintaining supplier quality agreements, specifications, and performance expectations.
• Monitor key supplier performance metrics (e.g., defect rates, on-time delivery, cost of poor quality).
• Identify performance trends and drive continuous improvement initiatives with suppliers.
• Execute the supplier development programs to improve process capability, reduce variability, and enhance product quality.
• Represent Global Supplier Quality in root cause investigations and resolution of supplier quality issues using structured problem-solving methodologies (e.g., 8D, DMAIC).
• Drive Supplier Corrective and Preventive Actions (SCAR/CAPA) and verify effectiveness of implemented actions.
• Execute non-conformances, deviations, and escalation processes across global supply base.
• Ensure supplier controls meet applicable regulatory requirements (e.g., ISO 13485, FDA, GMP).
• Support internal and external audits, inspections, and regulatory submissions related to supplier quality.
• Maintain audit readiness through proper documentation, traceability, and quality records.
• Partner with R&D, Engineering, and Operations on new product development and supplier integration activities.
• Provide supplier quality input into design controls, risk management, and validation activities.
• Work cross functionally with internal stakeholders and global suppliers.
• Mentor junior supplier quality professionals and provide technical guidance across the organization.
• Assist in cross-functional and cross-regional initiatives to drive harmonization and best practices.
• Influence decision-making through data-driven insights and supplier performance analytics.

Qualifications

• 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 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.
• Willingness to travel globally up to 30%.

Preferred Qualifications

• ASQ Certification (CQE, CQA, CSQP) or equivalent.
• Six Sigma Green/Black Belt.
• Experience in medical device, pharmaceutical, or other highly regulated industries.
• Experience supporting new product introduction (NPI) and supplier validation activities.

Benefits

• Medical, Dental, & Vision.
• Health Savings Accounts.
• Flexible Spending Accounts.
• Disability Benefits.
• Life Insurance.
• Voluntary Benefits.
• Paid Absences.
• 401k Benefits.

Equal Opportunity Employer

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.