GCP Compliance Oversight Manager, FSP
Thermo Fisher ScientificSalary not specified
- Full Time
- Junior (1 to 2 years)
Axsome Therapeutics Inc
Manager, Quality Assurance - GxP (GCP Auditing) Remote
Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
BiopharmaceuticalsIndustries
Requirements
Candidates should possess a Bachelor’s degree in a scientific discipline, such as Chemistry, Biology, or Pharmaceutical Sciences, and have at least 7 years of experience in Quality Assurance within the pharmaceutical industry, with a strong focus on GMP and GDP regulations. Experience with GCP auditing is highly desirable, along with a thorough understanding of CMC processes and regulatory guidelines. Strong knowledge of US, Canadian, and international regulatory requirements is essential, and relevant certifications such as CQE or equivalent are preferred.
Responsibilities
The Manager, Quality Assurance – GxP Auditing will execute GxP Quality Assurance auditing functions with an emphasis on Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) quality systems, engaging with cross-functional teams to evaluate processes and activities for compliance. They will contribute to the execution of the PTC GMP/GDP audit strategy, perform internal and external audits of CMOs and vendors, conduct inspection readiness activities, and assist in responding to regulatory authority inspections. The role also includes supporting the development and review of SOPs, maintaining knowledge of global regulations, and contributing to Quality Management System (QMS) implementation and operations related to GMP audit activities.
Skills
GxP Auditing
GMP
GDP
Regulatory Compliance
Quality Systems
SOP Development
Risk-Based Audit
Inspection Readiness
CMC Processes
Vendor Qualification
Axsome Therapeutics Inc
Develops therapies for CNS disorders
About Axsome Therapeutics Inc
Axsome Therapeutics develops therapies for central nervous system (CNS) disorders, focusing on conditions like major depressive disorder, treatment-resistant depression, and Alzheimer's agitation. Their main product, AXS-05, is an oral medication that works by blocking NMDA receptors in the brain, which helps regulate mood. This drug has shown positive results in clinical trials and has received special FDA status to speed up its approval process. Unlike many competitors, Axsome emphasizes addressing unmet medical needs in CNS disorders and aims to improve patient outcomes through rigorous research and development. The company's goal is to bring effective treatments to market, enhancing the quality of life for patients suffering from these conditions.
Key Metrics
New York City, New YorkHeadquarters
2012Year Founded
$430.7MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
201-500Employees