Director, Quality Assurance - GxP (GCP) Remote
Axsome Therapeutics IncFull Time
Senior (5 to 8 years)
Candidates must possess a Bachelor's degree or equivalent, with a minimum of 4+ years of clinical research experience in the pharmaceutical or biotechnology field. A Bachelor's degree is preferred. Essential qualifications include experience working within a GCP environment, solid knowledge of GCP compliance and regulatory inspection readiness, and a strong understanding of drug development and GCP compliance processes. The role also requires experience in problem-solving, negotiations, and collaborative team building, as well as solid knowledge of regulatory requirements governing clinical trials and industry best practices. Proficiency in Microsoft Office and the ability to resolve conflict constructively are necessary. Experience across all phases of the clinical study life cycle is preferred.
The GCP Compliance Oversight Manager will lead process improvement initiatives, conduct risk assessments, and support mitigation planning. They will assist in updating procedural documents, provide recommendations for efficiency and compliance, and support cross-functional teams in implementing process changes. The role involves contributing to training programs, representing the department on projects, and interacting with internal and external personnel. Responsibilities include evaluating clinical trial processes for adherence to documentation, developing and maintaining KPIs and metrics, providing feedback on process and documentation quality, and representing GCP Compliance in meetings. The manager will also perform other assigned duties.
Provides life sciences products and services
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.