Do you have the passion to join a young global biopharmaceutical whose sole mission is to improve the lives of patients bravely facing cancer? Does it excite you to be a part of a rapidly expanding company with multiple marketed products and a diverse and robust pipeline? If yes, you may be a great fit for our community of dedicated and innovative associates.
Your Impact at TESARO:
Manage quality system audits of external GCP/GLP vendors, clinical investigator sites internal GCP/GLP processes and documents. This position will establish, implement and maintain GCP and GLP compliance systems in support of all phases of the company clinical and non-clinical trials.
• Manage and conduct quality system audits of GCP/GLP vendors, sites, documents and internal departments.
• Manage and conduct trend analysis of audit observations. Identify and communicate to QA management all compliance risks.
• Represent QA on the clinical and non-clinical teams and provide compliance advice and guidance.
• Manage the resolution of compliance issues identified at clinical and non-clinical vendors and clinical sites and provide assessment of the impact of any deficiencies.
• Develop and implement improvements to internal programs as indicated by audit observations, new regulations, guidance documents, and industry standards.
• Participates in and facilitates TESARO’s preparations for regulatory inspections and acts as inspection host during regulatory agency inspections at TESARO.
• BS in a scientific discipline required. Experience in a regulated industry preferred.
• At least 10 years of QA experience in a GCP/GLP setting for all phases of clinical trials.
• Experience auditing GCP/GLP vendors who provide clinical trial and non-clinical study
services, internal GCP/GLP processes and documents, and clinical investigator sites.
• Knowledge of FDA and global Regulatory Standards and associated
• Working knowledge of quality risk management concepts.
TESARO is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Internal Number: 1800008K
Do you have the passion to join a young global biopharmaceutical whose sole mission is to improve the lives of patients bravely facing cancer? Does it excite you to be a part of a rapidly expanding company with multiple marketed products and a diverse and robust pipeline? If yes, you may be a great fit for TESARO and our community of dedicated and innovative associates.