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Manager/Senior Manager, Clinical and PV Quality at Axsome Therapeutics - ApplyBlast

Manager/Senior Manager, Clinical and PV Quality

Axsome Therapeutics

4 months ago

3.1 on Glassdoor

New York, NY

Hybrid

Full Time

Senior

1 applicant

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About this role

Axsome Therapeutics seeks a Manager/Senior Manager to provide Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) oversight for clinical trial activities and post-market processes. This role ensures quality and compliance with global regulations, ICH guidelines, and company standards while managing cross-functional relationships. The position involves leading audits, developing quality systems, and guiding teams on regulatory requirements to ensure readiness for inspections.

Responsibilities

Provide GCP and GVP oversight for clinical trial activities and records
Lead internal and external audits to ensure regulatory compliance
Develop and implement corporate quality systems for clinical programs
Guide teams on applicable regulations to identify and mitigate compliance risks
Facilitate GCP and GVP training for functional areas and personnel

Skills

Qualifications

Bachelor's degree in Life Sciences, Pharmacy, or related fieldCertification in GCP or GVP preferred

About Axsome Therapeutics

axsome.com

Headquarters

New York, New York, United States

Company Size

201-500 employees

Founded

2012

View Profile

Axsome Therapeutics is a biopharmaceutical company focused on developing novel therapies for central nervous system (CNS) conditions that have limited treatment options. Its pipeline and commercial programs include candidates such as AXS-05, AXS-12 and AXS-14, addressing disorders including major depressive disorder, Alzheimer’s disease agitation, migraine, narcolepsy and fibromyalgia. Axsome emphasizes innovative mechanisms of action and rigorous clinical development to deliver meaningful improvements in patient outcomes. The company is headquartered in New York City and advances programs through regulatory engagement and commercialization efforts.