Senior Manager, Validation
Listed on 2026-09-14
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Quality Assurance - QA/QC
Regulatory Compliance Specialist
Role:
Senior Manager of Validation at Pro Kidney, leading the on-site Validation team and serving as both a people leader and technical expert. Objectives include establishing operational goals, ensuring compliance with GAMP 5, 21 CFR Part 11, and FDA guidance, and streamlining validation processes.
Responsibilities:Responsibility encompass team leadership and development, resource management, cross-functional collaboration with QA, Manufacturing, and Engineering, and supporting regulatory inspections. The role involves hands‑on troubleshooting, driving continuous improvement projects, and promoting a culture of quality and compliance.
Qualifications:Bachelor’s degree in Life Sciences or Engineering; 7+ years in biopharma or related environment with at least 3 years in a leadership role; expert knowledge of GxPs, GAMP, CFRs, data integrity, and validation lifecycle; experience with calibration software, electronic document management, and GMP regulations.
Preferred skills:Preferred skills include familiarity with laboratory systems, automation controls, and cGMP investigation tools.
High-Value:High-Value: emphasis on computer system validation, data integrity, and regulatory compliance within biopharmaceutical validation frameworks.
Reporting and stakeholder collaboration are integral to the role.
Work setup:on‑site at Pro Kidney; no specific travel requirements indicated.
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