Senior Manager, Computer System Validation QA

📋 Description

• Provide QA oversight of the GCP/GVP computer system validation lifecycle, ensuring ongoing
• Review and approve computer system risk assessments to determine the scope and level of validation
• Review and approve IT change control and validation deliverables, including protocols, test
• Participate, review, and approve periodic system and user reviews, identifying and remediating
• Collaborate with IT and cross-functional stakeholders such as business owners, to establish and
• Support the computer system audit program by participating in audit activities including audit

🎯 Requirements

• Bachelor's or Master's degree in software, computer engineering, or technical field
• 8+ years of experience in quality systems development and maintenance within clinical and
• Excellent attention to detail and strong organizational skills
• Effective communication skills both written and verbal
• Demonstrated expertise in GxP computerized system validation/assurance (CSV/CSA) and system
• Working knowledge of applicable electronic-record, computerized-system, data-integrity

🎁 Benefits

• 100% employer-paid medical, dental, and vision premiums for you and your dependents
• 401(k) with employer match
• Employee Stock Purchase Program (ESPP)
• Pre-tax commuter benefits (transit and parking)
• Referral bonus for hired candidates
• Subsidized lunch and parking on in-office days