Brittany Gaines

SME in Global Radiopharmaceuticals Quality & Operations

Role: Head of Quality at Clarity Pharmaceuticals
Location: Philadelphia, PA, US
LinkedIn followers: 500 followers

About Brittany Gaines

Multidisciplinary and detail-oriented quality and operations professional with 16 years of experience in the radiopharmaceutical industry and 5 years in medical devices. Proven track record of thoughtful leadership, collaborative problem-solving, and a solution-focused mindset, coupled with a strong drive for growth and tackling complex challenges. Leads with emotional intelligence, emphasizing integrity, transparency, and respect to foster productive, trust-based relationships with a steadfast commitment to patient safety and executional excellence.

Experience

Head of Quality
Clarity Pharmaceuticals
Oct 2025 — Present
Leads the Quality function across QA, QC, validation, regulatory affairs, and documentation. • Drives inspection readiness and regulatory compliance through audit planning, inspection support, and remediation. • Assesses GMP readiness across internal and external manufacturing, mitigating supply chain risks. • Collaborates cross-functionally with R&D, manufacturing, clinical, and supply chain to integrate quality into operations. • Oversees QMS implementation, document control, CAPA, non-conformance, and change control. • Engages with regulatory agencies and advises senior leadership on quality and risk. • Supports vendor qualification, ensuring compliance and inspection preparedness.

Education

Ohio University
Bachelor's degree, Biochemistry

Skills

Radiochemistry
Technology Transfer
Research
Instrument Validation
Quality Control
Analytical Chemistry
Organic Chemistry
Solid Phase Extraction
Technical Writing
Technical Training
Technical Liaison
Technical Translation
Hplc
Sop
Validation
Chemistry
Medical Devices
Gmp
Uv/Vis
Life Sciences
R&D
Pharmaceutical Industry
Laboratory
Biotechnology
Cross-Functional Coordination
Data Analysis
Optimization
Cross-Cultural Communication Skills
Process Improvement Projects
Troubleshooting
Technical Analysis
Technical Operations
Project Management

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