VP, Quality Operations – Drug-Device Combinations (GMP)

United Therapeutics Corporation

Chapel Hill (NC)

On-site

USD 220,000 - 300,000

Full time

14 days+

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Job summary

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.

Responsibilities

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.