Position Title: Quality Planning & Supplier Development Leader (New Product Introduction) Department: Quality Biopharma/Lab & Medical/Food & Beverage/Energy Reports to: VP Quality/EHS/Regulatory Compliance Position has ability to work onsite 3 days and remote 2 days depending on business need)
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.
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 First Article Inspection (FAI) and PPAP (as applicable) Develop and execute a strategic supplier development program aligned with business growth and NPI requirements Risk mitigation in critical components Establish supplier segmentation and performance management Implement supplier quality tools: Lead supplier performance improvement initiatives based on: Cost of Poor Quality (COPQ) Drive First Article Inspection (FAI) and PPAP development. 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: Supplier quality management 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 Engineering, Manufacturing & Operations, Supply Chain & Procurement and Regulatory Compliance Support co-development initiatives with key suppliers and customers Bachelor's degree in engineering, Quality, or related field (master's preferred)
5-7+ years in Quality Assurance within manufacturing environments
Pharma/Biotech, Food & Beverage, Lab & Analytical/Medical Devices
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
Quality Planning & Supplier Development Lead in huntersville at Unknown Company
This position is listed as full time and able to be worked remotely.