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Senior Manager, GxP Computerized Systems Auditing

BeOne Medicines · San Mateo, CA · Quality Compliance Department

Employment type

Full-time

Work setting

On-site

Location

San Mateo, CA

Schedule

Day shift

Posted

Travel

Required

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Job overview

The Senior Manager, GxP Computerized Systems Auditing is an onsite role based in San Mateo, CA, with compensation not specified in the posting. This position supports the quality compliance team at BeOne Medicines by managing a risk-based audit program. This role exists to provide independent quality oversight of computerized systems in GxP-regulated environments. The manager assesses compliance risks and identifies control gaps to support inspection readiness and global quality objectives.

What you'll do

  • Develop and execute a global computerized systems audit strategy.
  • Lead audits of software vendors and cloud service providers.
  • Evaluate compliance with 21 CFR Part 11 and Annex 11.
  • Present audit trends to executive quality governance.
  • Support health authority inspections.

What we're looking for

Skills & competencies
full-time
day shift
san mateo ca
quality assurance
gxp
auditing
computerized systems
compliance
beone medicines
Work arrangement
  • Weekend coverage required

Benefits & perks

  • Competitive benefits package

Why this role

Focus on GxP computerized systems compliance and data integrity in a global environment.

About the employer

BeOne Medicines is hiring for this role. Industry: Offices of Certified Public Accountants. Sector: 54.

Additional details

Industry sector
54
Industry
Offices of Certified Public Accountants
Occupation code
15-1212.00
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