Manager/Senior Manager, Clinical and PV Quality
$120,000–$140,000 year
HybridNew York City, New York, United States or New York, United States
Job Summary
Partner with Clinical Operations, Pharmacovigilance, and Medical Affairs to drive a "first time right" approach on compliance journeys for ongoing trials and post-market activities. Manage cross-functional relationships as the lead Quality GCP and GVP representative, providing expertise on ICH, GCP, and GVP regulations to proactively identify risks and recommend mitigation. Develop and execute a risk-based audit program, including internal and external audits, while leading investigations into significant departures from GCP/GVP standards. Provide input on Quality systems, review clinical documentation, and develop GCP/GVP training for functional areas. Identify and report compliance trends, escalate issues to senior management, and contribute to the development of Clinical Operations, Safety, and Clinical Quality systems. Maintain relevant GxP knowledge to drive consistent quality standards and metrics across the organization.
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
- Proven ability to manage complex projects
- 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
Desired Qualifications
- Experience of hosting or managing GCP and/or GVP inspections is desirable
- Experience in clinical operations and handling trial essential documents is preferred
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