Department: Quality
Position Type: Exempt
Status: Full-Time
Location: Remote

Company Overview

Alzheon, Inc. is a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease and other neurodegenerative disorders. We are committed to developing innovative medicines by directly addressing the underlying pathology of devastating neurodegenerative disorders. Our lead Alzheimer’s clinical candidate, ALZ-801, is an oral agent in Phase 3 development as a potentially disease modifying treatment for AD. ALZ-801 is an oral small molecule that fully blocks formation of neurotoxic soluble amyloid oligomers in the brain. Our clinical expertise and technology platform are focused on developing drug candidates and diagnostic assays using a precision medicine approach based on individual genetic and biomarker information to advance therapies with the greatest impact for patients.

Our experienced and passionate drug development team is focused on applying precision medicine, cutting-edge disease biomarkers, brain imaging and unique biologic insights to advance therapies with the greatest impact for patients. We are seeking individuals with an entrepreneurial spirit to join our team and help make the first oral Alzheimer’s disease-modifying therapy a reality for patients and their families, in a few short years.

Position Overview

The Director of Quality Systems and Compliance is responsible for establishing and implementing procedures and processes to ensure inspection readiness and the surveillance of GxP compliance at Alzheon. This role ensures that systems and records are compliant with global regulatory requirements.

Key Responsibilities

• Direction and oversight for Internal and External audit program, including standards, and routine reporting of progress to plan
• Direction and oversight for the GxP Contract Organization Qualification Program
• Develop metrics and reporting systems for Compliance risk identification and remediation
• Perform training on global compliance standards, communicating industry trends and enforcement activities
• Leads Alzheon and Contract Organization Inspection Readiness
• Manages Alzheon’s electronic Quality Management System, including oversight of Document Control, Training, Deviations, CAPA program, Change Control and Audit program
• Leads Quality Management Review, including preparation activities and tracking of action items to closure.
• Ability to travel domestically and internationally up to 15%
• All other duties as assigned

Requirements

• Minimum of 10+ years of experience in Biotechnology quality and compliance roles
• Bachelor’s degree in related Life Sciences, Chemistry or Biological Sciences discipline, Masters preferred
• Knowledge of CMC requirements
• Strong knowledge of global GxP expectations and ICH requirements
• Experience in authorship or review of CMC and/or clinical regulatory submissions
• Experience in Phase III drug development GxP environment and commercial operations
• Excellent collaboration skills
• Comfortable working in a fast-paced team environment
• Excellent communication skills, and comfortable assuming leadership within teams and with external CMO’s, CTL’s, and CRO’s

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.

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