Quality Planning & Supplier Development Lead

Position Title: Quality Planning & Supplier Development Leader (New Product Introduction)Department: QualityCore Industry: Biopharma/Lab & Medical/Food & Beverage/EnergyReports to: VP Quality/EHS/Regulatory ComplianceLocation: Huntersville, NC (Position has ability to work onsite 3 days and remote 2 days depending on business need)

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Summary: The Leader of Quality Planning, New Product Introduction (NPI) & Supplier Development is responsible for leading quality strategy across the full product lifecycle, with a focus on new product introduction, supplier quality development, and Quality Management System (QMS) integration within biopharma, lab and analytical and medical applications.
This role ensures robust quality planning, supplier capability development, regulatory compliance, and seamless industrialization of product. The Manage will drive a proactive, data-driven quality culture across internal operations and the external supply base to support scalable growth, innovation, and operational excellence.Key Responsibilities: Establish and lead Advanced Product Quality Planning (APQP) frameworks tailored for regulated industriesDefine quality strategies aligned with business growth and new market expansionDrive risk-based methodologies (FMEA, CTQs, control plans) across product and process developmentAlign internal and supplier quality expectations with customer and regulatory requirementsLead quality execution across the NPI lifecycle: concept, design, validation, launch, post-launch monitoringEnsure robust design transfers into manufacturing and supply chainOversee:Design controls and technical reviewsProcess validation (IQ/OQ/PQ)First Article Inspection (FAI) and PPAP (as applicable)Drive Right First Time (RFT) and First Pass Yield (FPY) for new product launchesDevelop and execute a strategic supplier development program aligned with business growth and NPI requirementsLead supplier engagement early in NPI to ensure:Design for manufacturability (DFM)Process capability and scalabilityRisk mitigation in critical componentsEstablish supplier segmentation and performance managementStrategic, critical, and transactional suppliersDrive supplier qualification and onboarding processes including:Audits and capability assessmentsProcess validation alignment (IQ/OQ/PQ where applicable)Implement supplier quality tools:Supplier APQPPPAP/FAISupplier FMEA and control plansLead supplier performance improvement initiatives based on:Supplier PPMOn-time deliveryCost of Poor Quality (COPQ)Drive First Article Inspection (FAI) and PPAP development. xzbcwsv Lead qualification and onboarding of new suppliers aligned with NPI timelines.Develop supplier capability through Process audits, technical assessments, and Quality System evaluations (ISO 9001/ISO14001, etc.)Establish supplier performance metrics: Supplier PPM, On-time Delivery, Cost of Poor Quality (COPQ)Partner with Supply Chain to develop long term supplier partnerships and dual sourcing strategiesDrive corrective actions and continuous improvement with suppliers using structured methodologies (8D, DMAIC)Ensure NPI and supplier development processes are fully integrated into the QMS and aligned with:ISO 9001ISO 13485FDA regulations (be, 21 CFR Part 82)Standardize and enforce procedures:Design controlSupplier quality managementChange management (including supplier changes)CAPA processesEnsure audit readiness across internal operations and supplier baseEnsure compliance across core industries (Biopharma, Lab & Medical)Collaborate with Regulatory Compliance teams on:Product and material compliance (RoHs, REACH, CMRT,PFAS considerations)Supplier regulatory requirements and documentationMonitor evolving regulatory requirements impacting products and suppliersLead collaboration across: Engineering, Manufacturing & Operations, Supply Chain & Procurement and Regulatory ComplianceIntegrate suppliers into the broader ecosystem strategy (Technology, Service, Innovation Collaborators)Support co-development initiatives with key suppliers and customersManage and co-develop ecosystem approach through affiliations and regulators to drive core industry focus markets
You may be asked to do other responsibilities as they come up filler*
Qualifications/Experience: Experience with leadership and responsibilities that are requiredBachelor’s degree in engineering, Quality, or related field (master’s preferred)Six Sigma Green or Black Belt certified (a plus)5-7+ years in Quality Assurance within manufacturing environmentsExperience in regulated industries preferred: Pharma/Biotech, Food & Beverage, Lab & Analytical/Medical DevicesAPQP, PPAP, FMEA, Control PlansRoot cause analysis (8D, 5 Whys, Fishbone)Statistical analysis and digital quality systems (SPC, Cp/Cpk)Quality Management Systems (ISO 9001/ISO 13485- a plus)Supplier auditing and developmentRisk management frameworksStrong project management and program skillsStrategic/data driven decision making