Senior Manager, GxP Computerized Systems Auditing

Job overview

The Senior Manager, GxP Computerized Systems Auditing is an onsite role based in Emeryville, CA. Compensation is not specified for this position, which supports the Quality and IT departments in maintaining compliance for computerized systems. This role exists to manage and execute a risk-based audit program for computerized systems in GxP-regulated environments. It contributes to the company's goals by providing independent quality oversight and ensuring data integrity and regulatory compliance throughout the system lifecycle.

What you'll do

• Develop and maintain global computerized systems audit strategy
• lead internal and supplier audits
• evaluate third-party compliance
• assess GxP regulatory compliance
• evaluate cybersecurity and validation controls
• present audit trends and compliance metrics to executive governance
• support health authority inspections
• manage audit program SOPs
• provide leadership to audit team members.

What we're looking for

Skills & competencies

full-time

day shift

emeryville ca

gxp

computerized systems

auditing

compliance

data integrity

quality assurance

onsite

travel required

Work arrangement

• Weekend coverage required

Why this role

Requires 7+ years of computerized systems audit experience (or 5+ years with Master's degree). Expertise in 21 CFR Part 11 and ISPE GAMP required.

About the employer

BeOne Medicines is hiring for this role. Industry: Process, Physical Distribution, and Logistics Consulting Services. Sector: 54.