GxP Validation & QA Systems Manager

Exelixis Inc; Alameda (CA); Sur place; USD 145 000 - 184 000; Plein temps

Avantages offerts par ce poste

Comprehensive benefits package

401k plan with company contributions

Group medical, dental, vision

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus program

Stock purchase program

Long-term incentives

Vacation and holidays

Paid sick days

Résumé du poste

Exelixis Inc. is seeking a QA Process and Systems Manager to oversee risk-based validation and lifecycle compliance of GxP computerized systems. You will partner with IT, system owners, and vendors to ensure data integrity and audit readiness, driving continuous improvement across the lifecycle.

The role requires 5+ years in GxP validated applications, knowledge of regulatory guidelines, and strong communication and project management abilities. Alameda, CA on-site with competitive benefits.

Qualifications

• Bachelor's degree in science or related field and 7+ years of related experience.
• Experience on GxP validated applications in a pharmaceutical or regulated environment.
• Knowledge of 21 CFR Part 11, EU Annex 11, ICH GCP/GLP, data integrity principles.

Responsabilités

• Provide independent, risk-based QA oversight of GxP regulated computerized systems.
• Review and approve validation deliverables and change controls.
• Author and execute CSV implementation plans; manage timelines and actions.
• Create and run reports, track actions, ensure data quality and compliance.
• Support internal and external audits/inspections; drive issue resolution.

Connaissances

QA oversight

Regulatory knowledge

Communication skills

Project management

Formation

Bachelor's degree in science or related field

Outils

CSV/CSA knowledge

SaaS systems

Data integrity tooling

Description du poste

Exelixis Inc. is seeking a QA Process and Systems Manager to oversee risk-based validation and lifecycle compliance of GxP computerized systems. You will partner with IT, system owners, and vendors to ensure data integrity and audit readiness, driving continuous improvement across the lifecycle.

The role requires 5+ years in GxP validated applications, knowledge of regulatory guidelines, and strong communication and project management abilities. Alameda, CA on-site with competitive benefits.