Currently I have an opening for an Associate Director Quality Consultant located in Foster City, CA. Details for the position are as follows:

Technical Information:

• Hybrid position, Onsite Tuesdays-Thursdays
• 12-month contract position
• Pay: $90-$104 hourly, depending on experience level

Job Description:

• Serves as Quality Business Partner lead for assigned R&D functions, programs, and/or vendors.
• Handles multiple projects simultaneously and ensures overall and timely completion of tasks.
• Works closely with business to provide expert quality information, manage identified issues, and support continuous improvement.
• Acts as Subject Matter Expert supporting GCP cross portfolio risk assessment for all activities performed by assigned functions, vendors or relevant to assigned R&D programs.
• Collaborates with the Audit, Inspection and CAPA Management Team within R&D Quality as required on internal quality audits, regulatory agency inspections, risk assessment, deviations and CAPA activities.
• Assists in readiness preparation, and/or directly supports regulatory agency inspection.
• Supports deviation identification, reporting, and CAPA development.
• Supports evaluation of new regulations and potential implications for Gilead R&D and/or R&D vendors.
• Evaluates, writes, and/or reviews standard operating procedures, and performs other activities in support of an integrated cross-functional QMS.
• Collaborates with other R&D Quality teams to ensure assigned functions, programs or vendors have timely and robust support for quality data/ analytics and reporting, quality documentation and training, quality technology and systems validation, and other related activities.
• PharmD/PhD with 2 , master’s with 8 , or bachelor’s degree with 10 years of experience in GCP, Risk minimization and mitigation, continuous improvements, and QMS operations.