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 Manager of Clinical Quality works closely with Alzheon’s Clinical teams to support the clinical development programs across Alzheon’s portfolio of products. This role will provide clinical quality support to ensure adherence with Alzheon’s Quality policies, procedures, and applicable regulations.

Key Responsibilities

• Work in partnership with Clinical teams to facilitate appropriate and complete resolution, approval and oversight of findings/non-compliances, deviations, investigations, CAPAs in a timely manner
• Provide quality management oversight and facilitation of quality event management at CRO’s for assigned clinical programs and/or studies, including assessment of potential root causes and CAPA
• Support and lead cross-functional clinical teams and provide guidance related to GCP/GCLP requirements based on interpretation of current regulations and through the application of Alzheon’s procedures to ensure best practices and compliance
• Participate and lead GCP audits (e.g., clinical site audits, vendors, internal systems), in support of the clinical programs
• Facilitate and support the selection and qualification of third-party vendors, contract laboratory facilities and contractors, in partnership with the Clinical teams
• Manage the Clinical audit program in collaboration with the Clinical teams by scheduling audits, conducting pre-audit meetings, drafting audit plans, agendas, audit reports, and executing the audit program
• Provide quality review of internal procedures, clinical protocols, investigators brochure, clinical study reports and other relevant study documents as needed
• Clinical QA leadership for inspection readiness at clinical sites and vendors
• Leads Alzheon’s GCP internal audit program
• Report GCP quality metrics to ensure that quality standards are maintained across the clinical programs
• Work closely with Clinical and Quality management to ensure compliance to regulations, guidelines, and company SOPs
• 25% travel may be required
• All other duties as assigned

Requirements

• Bachelor’s degree in Life Sciences, Masters preferred
• A minimum of 8+ years of relevant experience in a Clinical QA role
• Extensive experience in Good Clinical Practice (GCP) required with proficiency/ knowledge of ICH, GCP, and applicable CFRs, guidance documents, systems processes, and procedures both US and globally
• Prior experience in working with Clinical Research Organizations and contracted central laboratories
• Detail oriented with excellent written and verbal communication skills
• Ability to effectively work independently, within prescribed guidelines, and as a team member
• Demonstrated ability to work efficiently in a dynamic, complex, and fast-paced team environment

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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