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About the Role

Axsome Therapeutics is seeking a Manager/Senior Manager Clinical and PV Quality to provide GCP and GVP oversight of clinical trial activities, ensuring quality and management in accordance with global regulations, ICH guidance, and company processes. This role involves managing stakeholder relationships and serving as the lead Quality GCP and GVP representative on clinical teams.

Responsibilities

• Partner with key functions to support a compliance journey and drive a "first time right" approach.
• Support the development, implementation, and improvement of corporate quality systems for clinical programs and post-marketing activities.
• Provide GCP / GVP requirements input into the development and implementation of Quality (GxP) systems.
• Provide expertise and guidance on applicable regulations to specialty pharma/clinical development and pharmacovigilance teams.
• Identify and address GCP / GVP compliance issues to ensure readiness for regulatory inspection.
• Develop and implement a risk-based GCP and GVP audit program.
• Execute GCP / GCP-GcLP / GVP internal or external audits.
• Develop and facilitate GCP/GVP/GXP training for relevant personnel.
• Identify, monitor, and report compliance trends and risks.
• Lead and support investigations into significant departures from GVP / GCP.
• Escalate compliance issues identified to senior management.
• Review and provide input to clinical documentation.
• Contribute to the development of Clinical Operations, Safety and Clinical Quality and Compliance, and Pharmacovigilance systems and standards.
• Develop and measure GCP and GVP quality metrics.
• Maintain relevant knowledge of GxP requirements and developments and communicate them.
• Provide information relating to Quality to stakeholders.

Requirements

• Bachelor’s degree in a scientific discipline or field.
• 5+ years of experience within the pharmaceutical and R&D industry.
• Minimum of 3 years hands-on GCP and/or GVP QA experience.
• Experience in a compliance role.
• Extensive knowledge and practical application of ICH, GCP / GVP and applicable guidance documents.
• Ability to proactively identify and anticipate risk of non-compliance in a complex environment.
• Experience of hosting or managing GCP and/or GVP inspections is desirable.
• Experience in clinical operations and handling trial essential documents is preferred.
• Proficient MS Office skills.
• Excellent planning and organizational skills.
• Exceptional attention to detail.
• Strong interpersonal skills and a team player.
• Ability to influence senior leaders within the organization on matters of quality importance.
• Effective communication skills, both verbally and written.
• Proven ability to manage complex projects.

Skills

• GCP
• GVP
• ICH
• MS Office

Location

• New York City

Work Type

• On-site (at least three days per week)

Experience Level

• Manager/Senior Manager

Education Level

• Bachelor’s degree in a scientific discipline or field

Salary/Compensations

• $120,000 - $140,000

Benefits

• Annual bonus
• Significant equity
• Generous benefits package

About the Company

• Axsome Therapeutics is a biopharmaceutical company focused on treating central nervous system (CNS) conditions.
• We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action.
• Our portfolio includes FDA-approved treatments for various neurological and psychiatric conditions.
• We are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish.

Equal Opportunity

• Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities.
• We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.