Vice President of Quality

Vice President, Quality Operations – Combination Products

Location: Research Triangle Park, NC (Onsite)

Relocation Assistance Available

A leading biopharmaceutical organization is seeking a Vice President of Quality Operations to provide strategic leadership for Quality Assurance and Quality Control functions supporting commercial pharmaceutical and combination product manufacturing.

This executive leader will oversee quality operations for drug product and medical device manufacturing, packaging, and distribution activities, ensuring compliance with global regulatory standards while driving operational excellence, inspection readiness, and continuous improvement.

Key Responsibilities

• Lead all Quality Operations activities across pharmaceutical and combination product manufacturing.
• Ensure compliance with FDA, EMA, and global GMP/GDP regulations.
• Oversee Quality Assurance and Quality Control organizations.
• Drive site inspection readiness and lead regulatory authority interactions.
• Support facility start-up, process validation, equipment qualification, and commercialization activities.
• Review and approve deviations, CAPAs, change controls, validation protocols, and batch disposition activities.
• Establish and maintain supplier quality programs and quality agreements.
• Partner with Manufacturing, Engineering, Regulatory Affairs, and Supply Chain to ensure product quality and operational success.
• Lead quality support for technology transfer and product launch initiatives.
• Champion continuous improvement initiatives that enhance compliance, efficiency, and product quality.
• Provide executive-level leadership for quality strategy and organizational development.

Required Qualifications

• Bachelor's degree in a scientific, engineering, or related technical discipline.
• 15+ years of progressive quality leadership experience within pharmaceutical, biotechnology, medical device, or combination product manufacturing environments.
• 10+ years of leadership experience managing quality organizations.
• Experience leading both QA and QC functions.
• Strong knowledge of FDA, EU, and international GMP regulations.
• Demonstrated success supporting regulatory inspections and audits.
• Experience with process validation, equipment qualification, quality systems, and manufacturing operations.
• Working knowledge of analytical testing, stability programs, and laboratory operations.
• Proven ability to build and lead high-performing quality teams within a highly regulated environment.

Preferred Qualifications

• Advanced degree (MS, MBA, PharmD, or PhD).
• Combination product, inhalation drug delivery, or drug-device experience.
• Experience supporting commercial-scale manufacturing operations and global regulatory submissions.