Director, Clinical Quality Assurance - Contractor

Required

• Education & Experience
• Bachelor’s or advanced degree in Biology, Chemistry, or related field.
• Minimum 10 years of ICH-GCP/GVP Quality Assurance experience.
• Experience with auditing (e.g. Investigator Sites, Clinical Trial Vendors, Processes).
• Strong understanding of small molecule products with direct experience in solid oral dosage forms.
• Knowledge/Skills/Abilities
• Extensive knowledge of FDA regulations and practices, ICH guidance, and strong knowledge of global health authority regulations and practices.
• Hands-on experience in drug life cycle management.
• A successful track record of working with service providers and CROs.
• Ability to make timely and sound quality decisions when faced with complex clinical, compliance, technical and regulatory considerations. Highly skilled in the ability to work with ambiguity and complexity.
• Knowledge of Quality Management Systems; experience in implementing and managing quality systems in the pharmaceutical industry.
• Excellent verbal and written communication skills.