Director, Global Medical Services Operations (East Coast Based Positio…
Axsome Therapeutics IncSalary not specified
- Full Time
- Senior (5 to 8 years)
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Life Sciences, Pharmaceuticals, Medical DevicesIndustries
Requirements
Candidates should possess a Bachelor’s degree in a relevant field, and a minimum of 10 years of experience in compliance, with at least 5 years in a leadership role. Strong knowledge of cGMP regulations and global quality systems is essential, along with experience working with regulatory agencies such as the FDA.
Responsibilities
The Sr. Director, Compliance will establish and lead a Global Quality Compliance strategy, develop and maintain quality assurance and compliance policies and standard operating procedures, and ensure compliance to all applicable regulations. They will also lead inspection readiness programs, provide on-site support for inspections, advise on industry issues and regulatory changes, and oversee efforts to respond to new or changing regulations, including communicating regulations to leadership and affected areas.
Skills
Regulatory Compliance
Quality Systems
cGMP
Inspection Readiness
Regulatory Affairs
Process Improvement
Leadership
Global Quality Management
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