Manager, Quality Assurance – GxP Auditing (GMP-GDP) - Remote
Axsome Therapeutics Inc- Full Time
- Senior (5 to 8 years)
Candidates should possess a good understanding of clinical trial processes related to sponsor and CRO activities, including but not limited to sponsor oversight, issue management, site management, and clinical monitoring. A minimum of 4+ years of clinical research experience in the pharmaceutical or biotechnology field is required, along with solid knowledge of drug development, clinical trial management, and/or GCP compliance processes. Proven track record of strong project management skills and experience managing clinical trial delivery activities for drug development programs is necessary, as well as experience in problem solving, negotiations, and collaborative team building with non-direct reports and other stakeholders. A BS, MS, or equivalent in a scientific field is required, and the ability to efficiently utilize computer software programs such as Microsoft Office for general use, project management, and presentations is essential. Candidates must be able to resolve conflict constructively and possess a valid driver’s license with the ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel.
As a GCP Compliance Oversight Manager, the role involves planning, monitoring, and reporting on quality and compliance for selected clinical trial delivery processes, determining adherence and understanding of ICH GCP requirements. The position requires providing project-level QA support, collaborating with internal and external teams, conducting proactive and routine evaluations of clinical trial processes, promoting awareness of quality and regulatory compliance standards, participating in quality improvement activities, and developing and maintaining metrics, charts, and dashboards to track process quality and compliance. It also includes coordinating governance and compliance management processes, implementing quality awareness objectives, developing and maintaining quality and compliance mentorship/reference materials and tools, providing near real-time feedback on study process and documentation quality, ensuring compliance with personal learning requirements, and performing other duties as assigned.
Provides life sciences products and services
Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.