Senior Global Supplier Quality Professional

🔥 2 hours ago

❄️ Minnesota – Remote

❄️ Minnesota – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 10%

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Kindeva Drug Delivery

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2020

🏥 Healthcare

💊 Pharmaceuticals

🏭 Manufacturing

💰 $42M Grant on 2023-09

Healthcare • Pharmaceuticals • Manufacturing

Kindeva Drug Delivery is a purpose‑fueled drug delivery CDMO (contract development and manufacturing organization) that provides development, analytical, manufacturing, fill-finish, regulatory and post-commercialization services focused on specialist drug delivery formats including sterile injectables, pulmonary (inhalation), nasal and dermal delivery. The company operates multiple facilities across the US and UK (Bridgeton, MO; Brentwood, MO; Maryland Heights, MO; Loughborough, UK; Clitheroe, UK; Woodbury, MN; Northridge, CA; Union City, CA; Lexington, KY; Germantown, MD) and emphasizes capabilities in aseptic/sterile manufacturing, advanced fill-finish operations, and drug-delivery platform technologies (autoinjectors, microneedle patches, pMDIs, nasal MDIs, dose counters, dual-chamber injectors). Kindeva positions itself as an innovation-driven partner helping pharmaceutical companies fast-track development and commercial supply, with investments in green propellants and Annex 1-compliant sterile facilities.

📋 Description

• 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.