A biopharmaceutical company in Wisconsin is seeking a Senior Manager for GxP Systems & Validation. This strategic role involves leadership for GxP-regulated computerized systems, ensuring compliance with global regulatory standards. The ideal candidate will have over 8 years of experience in GxP systems, a strong background in validation practices, and leadership capabilities. Competitive salary range is $145,000 — $165,000 USD, along with excellent benefits.
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
Provide strategic and operational leadership for GxP-regulated computerized systems.
Ensure alignment with global regulatory requirements.
Oversee administration and compliant operation of GxP systems.
Skills
Leadership
Validation strategy
Change control
Influencing stakeholders
Data integrity
Education
Bachelor’s degree in Life Sciences, Engineering, IT or related discipline
Tools
Laboratory Information Management Systems (LIMS)
Chromatography Data Systems
Spectrophotometry Systems
Job description
A biopharmaceutical company in Wisconsin is seeking a Senior Manager for GxP Systems & Validation. This strategic role involves leadership for GxP-regulated computerized systems, ensuring compliance with global regulatory standards. The ideal candidate will have over 8 years of experience in GxP systems, a strong background in validation practices, and leadership capabilities. Competitive salary range is $145,000 — $165,000 USD, along with excellent benefits.