GxP QA Systems & Validation Lead

Regulatory Jobs; Alameda (CA); On-site; USD 145,000 - 184,000; Full time

Benefits offered by this job

401k with company contributions

Medical, dental and vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus

Job summary

Exelixis in Alameda, CA seeks 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, business units and external vendors to ensure data integrity, audit readiness, and continuous improvement.

Responsibilities include approving validation deliverables, authoring CSV implementation plans, managing change controls, and generating metrics to support business goals.

Qualifications

• 7+ years of related experience in regulated environments.
• Experience with GxP validated applications.
• Knowledge of 21 CFR Part 11, EU Annex 11, ICH GCP/GLP.

Responsibilities

• 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 CSV implementation plans in a timely manner
• Develop solutions and manage project/change timelines, as requested
• Create and run reports, track follow-up actions and ensure data quality and compliance
• Support activities for internal and external audits/inspections

Skills

QA oversight

GxP knowledge

Regulatory processes

Data integrity

Cross-functional collaboration

Excellent communication

Education

Bachelor's degree in science or related field

Equivalent combination of education and experience

7 years of related experience

Tools

CSV/CSA tools

Validation tools

SaaS systems

Job description

Exelixis in Alameda, CA seeks 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, business units and external vendors to ensure data integrity, audit readiness, and continuous improvement.

Responsibilities include approving validation deliverables, authoring CSV implementation plans, managing change controls, and generating metrics to support business goals.