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
BiopharmaceuticalsIndustries
Requirements
Candidates should possess a Bachelor’s degree in a scientific discipline and a minimum of 10 years of progressively responsible experience in Quality Assurance or a related role within the pharmaceutical or biotechnology industry, with at least 5 years of experience in a clinically focused position. They must have detailed knowledge and understanding of Good Clinical Practice (GCP) regulations, demonstrated experience leading or conducting QA audits, and the ability to develop and execute risk-based audit plans. Furthermore, they should be able to develop and foster positive relationships with internal and external stakeholders, demonstrate leadership and mentoring abilities, and possess proficiency with Microsoft Office.
Responsibilities
The Director, Quality Assurance – GxP (GCP) will be responsible for managing GxP Quality Assurance functions with an emphasis on GCP compliance, partnering with Clinical Development/Operations on clinical study teams to ensure GCP compliance and identify process improvements, reviewing study-related documents and plans, developing and executing a GxP risk-based audit strategy, performing internal and external audits to assure compliance, assessing audit responses, leading front/backroom activities during regulatory inspections, advancing PTC’s understanding of worldwide regulations and GxP practices, managing, coaching, and mentoring direct reports, and performing other tasks and assignments as needed.
Skills
GxP
GCP
Quality Assurance
Regulatory Compliance
Clinical Trial Processes
Auditing
Risk Management
SOP Development
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