Vice President of Quality

Alexander Technology Group is looking for a VP of Quality for a start-up client in the Portsmouth, NH area. This is full-time Salary: 200-250k range This would be heavily on-site in Portsmouth. No 3rd party applicants will be consideredRequirements:Quality Strategy & LeadershipDevelop and execute the overall quality strategy aligned with company goals and regulatory expectations for combination products (e.g., FDA, EMA, ISO, ICH guidelines).Build and mentor a high-performing quality team, scaling resources as the company grows from early-stage development through commercialization.Serve as the company’s Quality Management Representative and key liaison with regulatory authorities during inspections and audits.Quality Systems & ComplianceEstablish and maintain a robust Quality Management System (QMS) compliant with 21 CFR Parts 210, 211, 820, 4, and ISO 13485.Oversee quality operations including document control, training, CAPA, change control, supplier qualification, and internal audits.Ensure compliance with cGMP, GLP, and GCP standards as applicable to combination product development and manufacturing.Manufacturing & Supplier QualityDevelop and manage supplier qualification programs and manufacturing oversight.Lead quality assurance activities related to contract manufacturing organizations (CMOs), contract development and manufacturing organizations (CDMOs), and testing labs.Oversee product release, lot disposition, and complaint handling.Regulatory & Inspection ReadinessCollaborate with Regulatory Affairs to ensure alignment on quality and compliance expectations across global markets.Lead preparation for FDA pre-approval inspections (PAI), ISO certification audits, and other regulatory inspections.Establish and maintain metrics to monitor product and process quality performance.If interested, please send resume to Jpolombo@alexandertg.com