Senior Manager GCP / GVP

JOB SUMMARY

The Senior Manager GCP / GVP

Pay Rate Range : $40.00 / hr. - $44.27 / hr.

JOB DESCRIPTION

SUMMARY / JOB PURPOSE :

The Senior Manager GCP / GVP QA is accountable for Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GVP) systems and activities, drives compliance and continuous improvement, ensures that Quality is integrated throughout GCP / GVP processes, supports and conducts audits as requested using a risk-based approach, implements Quality Risk Management (QRM), tracks and trends key metrics, and ensures clinical data integrity.

Develops and implements GCP and GVP functional strategy to support cross-functional deliverables to ensure that quality is embedded within all steps of clinical research and operations. Identifies and drives continuous improvement, partnering with Product Development, Clinical Development, Clinical Operations, study and project teams, Medical Affairs, Regulatory, and Global Patient Safety, and other functions, as applicable. Aligns key QA strategies with business goals and understands the global regulatory compliance landscape.

Represents QA as the QA Partner (Primary Point of Contact), speaking One Voice for Quality, for Exelixis business stakeholders, represents QA in an outwardly and business-facing capacity, in strategic and decision forums, and triages communication between business functions, internally or externally, and QA, to provide and ensure delivery on company core goals and pipeline deliverables.

EDUCATION / EXPERIENCE / KNOWLEDGE & SKILLS :

Education :

• BS / B.Sc preferably in the life sciences or STEM disciplines and a minimum of 6 years of related experience

Experience :

Knowledge / Skills :

WORKING CONDITIONS :

Facilities / Alameda :

TECHNICAL SKILLS

Must Have

Nice To Have

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated

Los Angeles county

, to the extent our customers

require

a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.