Talent.com
Vice President of Quality

Vice President of Quality

Alexander Technology GroupPortsmouth, NH, United States
11 days ago
Job type
  • Full-time
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

    Create a job alert for this search

    Vice President Quality • Portsmouth, NH, United States