Manager/Senior Manager, Clinical and PV Quality

Axsome Therapeutics•New York, NY

4h•$120,000 - $140,000•Hybrid

About The Position

Axsome Therapeutics is seeking a Manager/Senior Manager, Clinical and PV Quality to provide Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) oversight of clinical trial activities and associated records and processes. The role supports compliance with global regulations, including FDA, Health Canada, EMA, and MHRA requirements; relevant ICH guidance; company procedures; and other applicable regulations. The role manages relationships with internal and external stakeholders and serves as the lead Quality GCP and GVP representative on teams supporting company-sponsored clinical trials and post-market activities. This position reports to the Senior Vice President, Quality. It is based at Axsome’s headquarters in New York City and requires working onsite at least three days per week; fully remote candidates cannot be considered.

Requirements

Bachelor’s degree in a scientific discipline or field.
At least 5 years of experience in the pharmaceutical and R&D industry, including at least 3 years of 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 non-compliance risks in a complex environment.
Proficient in Microsoft Office.
Excellent planning and organizational skills.
Exceptional attention to detail.
Strong interpersonal skills and ability to work as a team player.
Ability to influence senior leaders on matters of quality importance.
Effective verbal and written communication skills.
Proven ability to manage complex projects.

Nice To Haves

Experience hosting or managing GCP and/or GVP inspections.
Experience in clinical operations and handling trial essential documents.

Responsibilities

Partner with Clinical Operations, Pharmacovigilance, and interface functions such as Medical Affairs and Commercial to support compliance and a “first time right” approach.
Support the development, implementation, and improvement of corporate quality systems for clinical programs and post-marketing activities.
Provide GCP and GVP requirements input into the development and implementation of Quality (GxP) systems.
Advise clinical development and pharmacovigilance teams on applicable regulations, proactively identify compliance risks, and recommend mitigation.
Identify and address GCP and GVP compliance issues across clinical and pharmacovigilance systems and processes, maintaining readiness for regulatory inspections.
Develop and implement a risk-based GCP and GVP audit program.
Conduct internal GCP, GCP-GcLP, and GVP audits and external audits for compliance with procedures, policies, contractual agreements, plans, and regulations or standards.
Develop and facilitate GCP, GVP, and GxP training for relevant functions and personnel.
Identify, monitor, and report compliance trends and risks for trials and post-market activities.
Lead and support investigations into significant GVP or GCP departures, including serious breaches and scientific misconduct.
Escalate identified compliance issues to senior management.
Review clinical documentation, including protocols, study reports, and investigator brochures, and provide input.
Contribute to the development of Clinical Operations, Safety, Clinical Quality and Compliance, and Pharmacovigilance systems and standards.
Develop and measure GCP and GVP quality metrics to promote consistent quality standards.
Maintain knowledge of relevant GxP requirements and developments, assess their impact on company procedures and compliance, and communicate relevant information to the QA team and management.
Provide Quality-related information to stakeholders as needed, such as information for the PV System Master File.