Manager/Senior Manager, Clinical and PV Quality

The role

This person will provide GCP and GVP oversight of clinical trial activities and related processes. They will manage cross functional relationships and act as the lead Quality representative for clinical teams.

What you will do

• Partner with key functions to support a compliance journey
• Support development and improvement of corporate quality systems
• Provide GCP and GVP requirements input for GxP systems
• Provide expertise on regulations to pharma and pharmacovigilance teams
• Identify and address GCP and GVP compliance issues
• Develop and implement a risk-based GCP and GVP audit program
• Execute internal and external audits
• Develop and facilitate GCP, GVP, and GXP training
• Identify, monitor and report compliance trends and risks
• Lead and support investigations into significant departures from GVP or GCP

Required qualifications

• 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 identify proactively and anticipate risk of non-compliance in a complex environment
• 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

Nice to have

• Experience of hosting or managing GCP and/or GVP inspections is desirable
• Experience in clinical operations and handling trial essential documents is preferred

Benefits

• Annual bonus
• Significant equity
• Generous benefits package

About the company

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. Their neuroscience portfolio includes FDA-approved treatments for several conditions.