Quality Planning & Supplier Development Lead

Position Title: Quality Planning & Supplier Development Leader (New Product Introduction)

Department: Quality

Core Industry: Biopharma/Lab & Medical/Food & Beverage/Energy

Reports to: VP Quality/EHS/Regulatory Compliance

Location: Huntersville, NC

• (Position has ability to work onsite 3 days and remote 2 days depending on business need)

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 industries
• Define quality strategies aligned with business growth and new market expansion
• Drive risk-based methodologies (FMEA, CTQs, control plans) across product and process development
• Align internal and supplier quality expectations with customer and regulatory requirements
• Lead quality execution across the NPI lifecycle: concept, design, validation, launch, post-launch monitoring
• Ensure robust design transfers into manufacturing and supply chain
• Oversee:
• Design controls and technical reviews
• Process 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 launches
• Develop and execute a strategic supplier development program aligned with business growth and NPI requirements
• Lead supplier engagement early in NPI to ensure:
• Design for manufacturability (DFM)
• Process capability and scalability
• Risk mitigation in critical components
• Establish supplier segmentation and performance management
• Strategic, critical, and transactional suppliers
• Drive supplier qualification and onboarding processes including:
• Audits and capability assessments
• Process validation alignment (IQ/OQ/PQ where applicable)
• Implement supplier quality tools:
• Supplier APQP
• PPAP/FAI
• Supplier FMEA and control plans
• Lead supplier performance improvement initiatives based on:
• Supplier PPM
• On-time delivery
• Cost of Poor Quality (COPQ)
• Drive First Article Inspection (FAI) and PPAP development.
• 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 strategies
• Drive 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 9001
• ISO 13485
• FDA regulations (be, 21 CFR Part 82)
• Standardize and enforce procedures:
• Design control
• Supplier quality management
• Change management (including supplier changes)
• CAPA processes
• Ensure audit readiness across internal operations and supplier base
• Ensure 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 documentation
• Monitor evolving regulatory requirements impacting products and suppliers
• Lead collaboration across: Engineering, Manufacturing & Operations, Supply Chain & Procurement and Regulatory Compliance
• Integrate suppliers into the broader ecosystem strategy (Technology, Service, Innovation Collaborators)
• Support co-development initiatives with key suppliers and customers
• Manage 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 required

• Bachelor'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 environments
• Experience in regulated industries preferred: Pharma/Biotech, Food & Beverage, Lab & Analytical/Medical Devices
• APQP, PPAP, FMEA, Control Plans
• Root 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 development
• Risk management frameworks
• Strong project management and program skills
• Strategic/data driven decision making