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 scientific discipline and a minimum of 6 years of relevant experience in Quality Assurance or a related role within the pharmaceutical, biotechnology, or a similar industry. They must demonstrate knowledge and understanding of global GVP regulations, primarily focusing on EMA and FDA guidelines, and have experience leading or conducting QA audits. Strong communication skills, both verbal and written, are essential, along with proficiency in Microsoft Office and the ability to work independently and collaboratively in a fast-paced environment.
Responsibilities
The Manager, Quality Assurance – GxP (GVP) will partner with the Pharmacovigilance function to ensure GVP compliance, identify and communicate pharmacovigilance-related risks and opportunities for process improvement, perform internal and external audits to assure compliance with GVP regulations and guidelines, communicate audit results and write reports, assess audit responses and ensure closure of CAPAs, participate in regulatory authority inspections and assist with GxP inspection readiness activities, maintain effective relationships with colleagues and departments, ensure appropriate escalation of quality issues, engage in quality system continuous improvement initiatives, and perform other tasks as assigned by management.
Skills
GxP
GVP
Pharmacovigilance
Audit
Regulatory Compliance
CAPA
Inspection Readiness
Process Improvement
Cross-functional Collaboration
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