Director of Quality Assurance
Bestow$215,000 - $240,000/year
Full Time
Expert & Leadership (9+ years)
[Remote] Associate Director, Quality Assurance – Combination Products at Axsome Therapeutics Inc
Remote
Not SpecifiedCompensation
N/AExperience Level
N/AJob Type
Not SpecifiedVisa
N/AIndustries
Requirements
- Strong background in drug delivery systems, medical devices and combination product regulations
- Exceptional organizational, clear communication, and interpersonal skills
- Strategic agility
- Experience with quality standards/specifications, methods, systems, and metrics for clinical and commercial quality operations
- Knowledge of medical device and combination product regulations and industry best practices
- Experience with design control, risk management, and validation
- Experience with regulatory audits
- Ability to collaborate with cross-functional teams and external partners
- Availability for 5-15% travel, both domestically and internationally
Responsibilities
- Oversee the quality and compliance of combination products, ensuring they meet regulatory standards and company objectives
- Develop and implement quality strategies and processes for combination products, in alignment with company goals and regulatory requirements
- Act as the QA contact for all quality-related inquiries and issues concerning device and combination product
- Collaborate with cross-functional teams to ensure quality and compliance throughout the combination product lifecycle
- Help define and implement quality standards/specifications, methods, systems, and metrics for clinical and commercial quality operations
- Stay up-to-date with changes in medical device and combination product regulations and industry best practices
- Participate in the development, review and approve of product documentation, including design control, risk management, and validation
- Identify gaps and improvement opportunities within the Design History File and Risk Management and track to closure
- Collaborate with external partners and suppliers to ensure their quality and compliance with company standards
- Perform quality assurance oversight for validation studies conducted by external partners
- Communicate effectively with senior management to provide updates on the status of quality and compliance for medical device/ combination product
- Participate in preparation for and execution of regulatory audits. Ensures audit observations related to functional area are addressed appropriately and completed on schedule
- Act as the Quality representative on assigned product teams to advocate compliance and quality assurance
Skills
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.
New York City, New YorkHeadquarters
2012Year Founded
$430.7MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
201-500Employees