Director Or Sr Director Qa Gcp Jobs in California

•Management of GCP QA audit initiatives, quality systems, and provision of internal/clinical study team support

•Requires at least 8 years of prior managerial experience

•Bachelor's degree in a scientific field or equivalent qualification

Key areas of responsibility encompass:

•This position holds a direct reporting line to the Vice President of Quality

•Ensures proper and timely escalation of quality matters, including potential misconduct or significant deviations in projects/products

Expert knowledge of ICH, GLP, GCP, and GMP FDA regulatory requirements, with previous experience in the US and Europe

Previous experience as Head of QA preferred

Outstanding interpersonal and communication skills, including scientific writing/editing, presentation, and verbal communication

Provide Quality Assurance oversight and support of ongoing GxP activities for clinical-stage development.

Develop and maintain GxP Standard Operating Procedures (SOPs) policies and controlled documents in partnership with the teams.

Ensure compliance with established company quality policies, practices, standard operating procedures (SOPs) and regulations

~8+ years of experience in Quality Assurance, working within clinical research (pharma, biotech or CRO backgrounds are acceptable)

Strong GCP or GXP experience (as an individual, not just working for a company who uses them)

Experience of implementing new electronic systems (both in-house and with vendors) and takes responsible for maintaining the quality of those systems.

You will meet the following requirements:

We are open to all levels from Associate Director to Sr Director.

If you meet the above criteria, please apply immediately with your latest resume for instant consideration.