Vice President, Quality Operations – Combination Products

United Therapeutics Corporation; Chapel Hill (NC); Sur place; USD 220 000 - 300 000; Plein temps

Résumé du poste

Scorpion Therapeutics in RTP, North Carolina, seeks a Vice President of Quality Operations for Combination Products to lead quality functions for Dry Powder Inhalation and Soft Mist Inhaler manufacturing sites. This senior role oversees GMP/GDP compliance, regulatory filings, and continuous quality improvement across both drug and device operations.

You will steer validation programs, vendor quality agreements, inspections, and regulatory interactions, shaping global quality strategies and

Qualifications

• Bachelor's in a scientific field; 15+ years in pharma/chemicals quality with growing responsibility.
• 10+ years leading QA/QC teams; 7+ years in FDA, USP, EP testing.
• Experience with stability programs and analytical instrumentation (HPLC, GC, UV/VIS, FTIR).
• Knowledge of US, EU, JP GMPs; strong leadership and regulatory skills.

Responsabilités

• Ensure GMP/GDP compliance across drug and device manufacturing, labeling, and packaging.
• Lead quality procedures during facility startup, including validation and regulatory filings.
• Manage Health Authority inspections.
• Establish quality standards collaboratively with manufacturing.
• Oversee documentation, risk assessments, CAPAs, and vendor quality agreements.
• Adapt quality systems for combination products, drive continuous improvement, and support regulatory submissions and compliance strategies.

Connaissances

Regulatory leadership

GMP/GDP compliance

Quality systems development

Risk management

People leadership

Formation

Bachelor's degree in a scientific field

Master's degree (preferred)

Outils

HPLC

GC

UV/VIS

FTIR

Description du poste

Role

Vice President of Quality Operations for Combination Products, overseeing quality functions for Dry Powder Inhalation and Soft Mist Inhaler manufacturing sites.

Responsibilities

• ensure compliance with GMP/GDP and global regulations across drug and device manufacturing, labeling, and packaging;
• lead quality procedures during facility startup, including validation and regulatory filings;
• manage Health Authority inspections;
• establish quality standards collaboratively with manufacturing;
• oversee documentation, risk assessments, CAPAs, and vendor quality agreements;
• adapt quality systems for combination products, drive continuous improvement, and support regulatory submissions and compliance strategies.

Requirements

• Bachelor's in a scientific field;
• 15+ years in pharma or chemicals quality with growing responsibility;
• 10+ years managing QA and QC teams;
• 7+ years in FDA, USP, EP testing;
• experience with stability programs, analytical instrumentation (HPLC, GC, UV/VIS, FTIR);
• knowledge of US, EU, JP GMPs;
• strong leadership, organizational, and regulatory skills.

Preferred

• Master’s degree.

High-Value

• biologics or drug-device combination products;
• sterile inhalation manufacturing;
• global GMP compliance;
• FDA and international regulatory interactions;
• senior leadership in quality operations.

Work setup

on-site RTP, North Carolina; relocation support may be available.