Senior Manager, GxP Systems & Validation Leader

Arrowhead Pharmaceuticals; Verona (WI); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Competitive salary

Excellent benefit package

Job summary

A leading biopharmaceutical company is seeking a Senior Manager for GxP Systems & Validation in Wisconsin. This role involves strategic governance and oversight for GxP-regulated computerized systems, ensuring compliance with global regulatory requirements. Candidates must have extensive experience in GxP systems and a strong leadership background. The position offers opportunities for developing staff and driving compliance initiatives. Competitive salary and benefits are included.

Qualifications

• 8+ years of experience in GxP computerized systems and validation.
• 3+ years in a leadership or program management role.
• Deep expertise in CSV/CSA, GAMP 5, 21 CFR Part 11.

Responsibilities

• Maintain governance frameworks for GxP computerized systems.
• Oversee administration and compliant operation of GxP systems.
• Lead, mentor, and develop validation and system administration staff.

Skills

GxP computerized systems experience

Leadership and program management

Stakeholder influence

Change control and deviation management

Education

Bachelor’s degree in Life Sciences, Engineering, IT or related discipline

Advanced degree preferred

Tools

Laboratory Information Management Systems (LIMS)

Chromatography Data Systems

Spectrophotometry Systems

Job description

A leading biopharmaceutical company is seeking a Senior Manager for GxP Systems & Validation in Wisconsin. This role involves strategic governance and oversight for GxP-regulated computerized systems, ensuring compliance with global regulatory requirements. Candidates must have extensive experience in GxP systems and a strong leadership background. The position offers opportunities for developing staff and driving compliance initiatives. Competitive salary and benefits are included.