Vice President of Quality

Job Description

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 considered

Requirements:

Quality Strategy & Leadership

• Develop 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 & Compliance

• Establish 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 Quality

• Develop 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 Readiness

• Collaborate 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