More jobs:
Vice President, Quality Operations – Combination Products
Job in
Chapel Hill, Orange County, North Carolina, 27517, USA
Listed on 2026-10-06
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-10-06
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
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.
- 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.
- Master’s degree.
- biologics or drug-device combination products;
- sterile inhalation manufacturing;
- global GMP compliance;
- FDA and international regulatory interactions;
- senior leadership in quality operations.
on-site RTP, North Carolina; relocation support may be available.
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×