Manager, Quality Assurance – GxP Auditing (GMP-GDP) - Remote
Axsome Therapeutics IncSalary not specified
- Full Time
- Senior (5 to 8 years)
Not SpecifiedCompensation
Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceutical, BiopharmaceuticalIndustries
Requirements
Candidates should possess a Bachelor’s degree in business or a scientific/technical field, and a minimal of 15 years of experience in multinational pharmaceutical or biopharmaceutical organizations, with global quality systems and quality operations roles. An advanced degree is desired, along with experience in strategy development and deployment, organizational change, and business improvement. Strong leadership skills and the ability to travel frequently, including internationally (25-40%), are also required.
Responsibilities
The Sr. Director will lead the continuous development, deployment, and improvement of the global Quality Management System (QMS), ensuring high cGMP compliance and supporting PSG objectives. Key responsibilities include developing and maintaining QMS elements, establishing a system for corrective and preventive measures, improving QMS efficiency, building relationships with professional organizations, establishing a risk-based QMS, developing and communicating Quality Manuals and policies, leading Communities of Practice, providing leadership to the Global Quality Organization, ensuring proper governance of Quality systems, leading Quality integration efforts, and handling customer issues.
Skills
cGMP
Quality Management System (QMS)
Risk-Based QMS
Corrective and Preventive Measures
Quality Manuals
Policies
Governance
Quality Integration
Customer Issues
Leadership
Strategy Development
Organizational Change
Business Improvement
Thermo Fisher Scientific
Provides life sciences products and services
About Thermo Fisher Scientific
Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.
Key Metrics
Waltham, MassachusettsHeadquarters
1956Year Founded
$17MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees