Creative and innovative professional with over thirty years of experience in the pharmaceutical and medical device industries. Demonstrates exceptional leadership, quality and process improvement, technical expertise, problem-solving abilities, and planning/scheduling skills. This multifaceted and extensive background encompasses investigational material and commercial organizations with diverse operations across the U.S., Puerto Rico, Asia, and Europe. Proficient in pharmaceutical materials and systems, with a deep understanding of applications and regulations for a wide range of dosage forms, including sterile liquid and lyophilized products, creams, tablets, and transdermals. Additionally experienced in Active Pharmaceutical Ingredients (API), gene therapy, and medical devices. Adept at performing GMP, GLP, and GCP compliance assessments at various global sites. Possesses excellent communication, interpersonal, organizational, and leadership skills.

Contact: TimReinhardt@phase1qualityconsulting.com