GxP QA Systems & Validation Manager

Exelixis; Alameda (CA); Presencial; USD 145.000 - 184.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401k plan with generous company match

group medical insurance

dental and vision coverage

life and disability insurance

flexible spending accounts

annual bonus program

Descripción de la vacante

Exelixis in Alameda, CA is seeking a QA Process and Systems Manager to provide risk-based QA oversight of GxP validated applications, managing end-to-end lifecycle from validation through operation and retirement, and ensuring data integrity and inspection readiness.

You will partner with IT, data owners, and external vendors, review deliverables, drive continuous improvement, support audits, and lead CSV to CSA transformations, with about 5% travel.

Formación

• Bachelor's degree in science or related field and 7 years of related experience; or, Equivalent combination of education and experience.
• 5+ years of experience working on GxP validated applications in a pharmaceutical or regulated environment.
• Experience and knowledge of the quality and regulatory business processes.
• Direct hands-on experience implementing GxP computerized systems and maintaining validated state.

Responsabilidades

• Provide independent, risk-based QA oversight of GxP regulated computerized systems for IT, Clinical Data Management and other functional systems, as applicable.
• Review and approve validation deliverables (risk assessments, validation plans and tests, user acceptance tests, test evidence, summary reports, change controls, deviations).
• Author and execute of CSV implementation plans in a timely, as requested.
• Develop solutions and manage project/change timelines, as requested.
• Create and run reports, track follow-up actions and ensure data quality and compliance.

Conocimientos

Process improvement

Business & tech skills

Communication skills

Idea communication

Team player

Regulatory guidelines

Database basics

Networking basics

SaaS familiarity

Confidential data handling

Results orientation

Educación

Bachelor's degree in science or related field

Equivalent combination of education and experience

Descripción del empleo

Exelixis in Alameda, CA is seeking a QA Process and Systems Manager to provide risk-based QA oversight of GxP validated applications, managing end-to-end lifecycle from validation through operation and retirement, and ensuring data integrity and inspection readiness.

You will partner with IT, data owners, and external vendors, review deliverables, drive continuous improvement, support audits, and lead CSV to CSA transformations, with about 5% travel.