Senior Global Supplier Quality Professional
Posted 16ds ago
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Job Description
Senior supplier quality professional managing audits, CAPA, and supplier improvement for Kindeva’s life-saving healthcare products. Ensuring global compliance with ISO, FDA, and GMP requirements.
Responsibilities:
- Execute global supplier quality strategies, policies, and procedures across regions and business units.
- Ensure supplier quality processes align with QMS requirements and regulatory standards.
- Partner with Global Supply Chain and Procurement on supplier segmentation, risk classification, and oversight models.
- Assist with supplier selection, qualification, onboarding, and inclusion in Approved Supplier Lists.
- Conduct and/or lead supplier audits, including initial, surveillance, and for-cause audits.
- Maintain supplier quality agreements, specifications, and performance expectations.
- Monitor supplier performance metrics such as defect rates, on-time delivery, and cost of poor quality.
- Identify performance trends and drive continuous improvement initiatives with suppliers.
- Execute supplier development programs to improve process capability, reduce variability, and enhance product quality.
- Represent Global Supplier Quality in root cause investigations and resolve supplier quality issues using structured methodologies such as 8D and DMAIC.
- Drive Supplier Corrective and Preventive Actions (SCAR/CAPA) and verify effectiveness.
- Execute non-conformance, deviation, and escalation processes across the global supply base.
- Ensure supplier controls meet applicable ISO 13485, FDA, and GMP requirements.
- Support internal and external audits, inspections, and regulatory submissions related to supplier quality.
- Maintain audit readiness through documentation, traceability, and quality records.
- Partner with R&D, Engineering, and Operations on new product development and supplier integration.
- 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.
- 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.
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 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%.
- ASQ Certification (CQE, CQA, CSQP) or equivalent preferred.
- Six Sigma Green/Black Belt preferred.
- Experience in medical device, pharmaceutical, or other highly regulated industries preferred.
- Experience supporting new product introduction (NPI) and supplier validation activities preferred.
