JOB SUMMARY

Axsome Therapeutics is seeking a Clinical Quality Sr. Specialist/Manager to provide quality oversight of internal and external clinical trial activities and related records and processes to assure management in accordance with FDA regulations, ICH-GCP, SOPs, and all other applicable regulations. This role assists with tasks necessary to achieve department and/or company goals and will report directly to the VP, Quality.

This is a hybrid role based at Axsome’s HQ in New York City. 

JOB RESPONSIBILITIES

• Support the development, implementation, and improvement of corporate quality systems that support early, mid and late phase clinical programs
• Identify and address GCP compliance issues across Axsome clinical systems and processes to ensure a state of readiness for regulatory inspection
• Conduct internal audits of Clinical GCP processes for adherence to SOPs, company policies, and regulations/standards, to include clinical study report audits and trial master file audits
• Plan, conduct, oversee and tracking GCP and GcLP audits of external contract laboratories and CROs to assure compliance with internal procedures and regulatory guidelines
• Assist in resolving compliance issues at clinical sites, clinical vendors, and laboratories; and providing assessment of the impact of any deficiencies
• Assist with ICH/GCP Training at investigator meetings and internally
• Identify and monitor clinical compliance trends and risks for Axsome clinical trials. Escalate compliance issues identified to senior management
• Review and provide input to clinical documentation (e.g. protocols, study reports, IB)
• Contribute to the development of Clinical Operations, Safety and Clinical Quality and Compliance systems and standards
• Develop and measure GCP quality metrics to drive consistent quality standards throughout the organization
• Maintain relevant knowledge of appropriate GxP requirements and developments as they impact company SOPs and compliance with GxP and communicate these to the QA team and QA management, as applicable
• Up to 10% travel may be required
• Perform other work-related duties as assigned

QUALIFICATIONS

• Sr. Specialist: A BA or BS degree in a scientific discipline strongly preferred. At least three (3) years’ experience (5 preferred) working in a GCP quality role in the pharmaceutical clinical research industry required. 
• Manager: A BA or BS degree in a scientific discipline strongly preferred. At least 5 years’ experience (7 preferred) working in a GCP quality role in the pharmaceutical clinical research industry. 1-2 years previous management or supervisory experience required.
• Proficient knowledge of ICH, GCP, and applicable CFRs, guidance documents, systems processes, and procedures
• Experience in clinical operations and handling trial essential documents preferred
• Additional experience conducting GMP/GLP audits a plus
• Great attention to detail
• Strong interpersonal skills
• Effective communication skills, both verbal and written
• Proven ability to manage complex projects

SALARY & BENEFITS

The anticipated salary range for this role is $82,000 - $95,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.