Axsome Therapeutics
Manager/Senior Manager, Clinical and PV Quality
New York, NY · Senior
Sponsorship not specifiedDetected 16 days ago
GCPFDA RegulatoryPharmacovigilanceGxP
About the role
- This position will report to the Senior Vice President, Quality.
- This role is based at Axsome's HQ in New York City with an on-site requirement of at least three days per week.
- We are unable to consider candidates who are looking for fully remote roles.
Responsibilities
- Support the development, implementation, and improvement of corporate quality systems that support early, mid and late phase clinical programs and post marketing activities.
- Develop and implement a risk-based GCP and GVP audit program.
Company info
- This role is based at Axsome's HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles.
- Execute GCP / GCP-GcLP / GVP internal audits (i.e. adherence to SOPs, company policies, and regulations/standards) or external audits (adherence to contractual agreements, plans and regulations / standards).
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