GCP Compliance Oversight Manager, FSP
Thermo Fisher ScientificSalary not specified
- Full Time
- Junior (1 to 2 years)
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, BiotechnologyIndustries
Requirements
Candidates should possess a Bachelor’s degree in a relevant scientific field, such as Chemistry, Biology, or Pharmaceutical Sciences, and have a minimum of 7 years of experience in Quality Assurance within the pharmaceutical or biotechnology industry, with a strong focus on GMP and GDP regulations. Demonstrated expertise in conducting internal and external audits, managing inspection readiness, and developing CAPA plans is essential. Experience with CMC processes and clinical trial materials is highly desirable, along with knowledge of global regulatory requirements including FDA, EU, and other international guidelines.
Responsibilities
The Manager, Quality Assurance – GxP Auditing will execute GxP Quality Assurance auditing functions emphasizing GMP and GDP quality systems for commercial and clinical activities, engaging with cross-functional teams to evaluate processes and procedures. They will contribute to the development and implementation of a risk-based audit strategy, conduct internal and external audits of CMOs, laboratories, and vendors, and support inspection readiness activities. Furthermore, the role involves assisting with GxP inspection activities, communicating audit results, assessing audit responses, and contributing to the development and review of SOPs, while maintaining awareness of current regulations and guidelines related to GMP and GDP activities.
Skills
GxP Auditing
GMP
GDP
Quality Systems
Regulatory Compliance
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