Established Search · 10 hours ago
Director of Quality Assurance
United States
Full-time
Remote
Director/Executive
15+ years expEstablished Search is an innovative organization at the forefront of radiopharmaceutical development, seeking a senior Quality Assurance leader to build, lead, and elevate quality systems across clinical and commercial operations. This highly visible role involves overseeing GMP compliance, regulatory strategy, and cross-functional leadership within nuclear medicine.
Staffing & Recruiting
Hiring Manager
Sam Powell
Responsibilities
Own and evolve an end-to-end Quality Management System aligned with FDA, EMA, and ICH expectations
Act as the senior quality authority for GMP compliance, including preparation for and leadership of regulatory inspections
Provide strategic oversight for quality input into regulatory submissions (e.g., INDs)
Lead batch review and product disposition for radiopharmaceutical products
Oversee investigations related to deviations, OOS results, complaints, and non-conformances, ensuring robust root cause analysis and CAPA
Drive quality metrics, trending, and continuous improvement initiatives
Partner closely with Manufacturing, R&D, Regulatory, and Clinical teams to embed quality across the organization
Build, mentor, and develop a high-performing QA team, including training programs and SOP development
Serve as a trusted quality advisor to senior leadership
Qualification
Required
Bachelor's or Master's degree in Chemistry, Biology, or a related scientific discipline
15+ years of QA experience within the pharmaceutical industry; radiopharmaceutical or PET drug experience is a strong plus
Deep hands-on knowledge of GMP regulations, including 21 CFR Parts 210, 211, and 212
Proven track record leading inspections, audits, and complex quality investigations
Strong leadership presence with the ability to influence across functions
Preferred
GMP, Six Sigma, or other quality certifications preferred
Company
Established Search
Established Search is a global executive search firm focused on providing talent solutions across a broad range of job functions.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase