- The Sr Manager or Director of GCP Quality Assurance will be responsible for the quality oversight of the GCP activities internally and externally with vendors, consultants and service providers. The Senior Manager of Clinical Quality Assurance will be well-versed with FDA regulations. This position will work closely with members of the clinical operations team and regulatory affairs to ensure FDA compliance for Landos sponsored clinical trials. Participates in the development, implementation and management of clinical quality systems
- Author and approve clinical and QA systems related SOPs and work instructions
- Review clinical protocols, amendments, informed consent forms, investigator brochures, clinical study reports and others as applicable
- Review and audit Trial Master Files for compliance
- Assess the accuracy and quality of scientific data collected against applicable regulatory regulations
- Ensure quality incidents are fully investigated, root cause analysis is defined and that CAPA has been implemented and monitored for effectiveness
- Identify potential risks in trial management activities and work collaboratively to mitigate the risks
- Oversee the management of the clinical audit program and performs internal and external audits of Landos and associated CROs
- Analyzes audit findings for trends and provides reports to the clinical management team
- Provide training on GCPs, SOPs and CAPAs from applicable audit findings
- Prepares the company and associated CROs for regulatory inspections
- During regulatory inspections plays a lead role as facilitator and communicator
- Identifies opportunities for improving quality and clinical processes.
- B.S in related scientific discipline, required
- M.S. in related scientific discipline, preferred
- Minimum 8-10 years of clinical research experience in the pharmaceutical industry, required
- Minimum 5 years of clinical quality assurance experience in the pharmaceutical industry, or CRO.
- Proficient with MS Office Suite and Excel
- Excellent communication skills-verbal and written
- Solid understanding of GCP, ICH and FDA regulations specific to pharmaceutical development
- Develops and maintains constructive relations with key internal and external colleagues, e.g., cross functional colleagues within Landos, and Health Authority representatives.
- Primarily remote work with occasional on-site attendance as required
- This position requires rare to occasional travel; domestic and international, the average travel for this position is 5-10% with some variation based upon business needs.
Position Type and Expected Hours of Work
- This is a full-time position