Global Head, Quality Control Processes and Programs

The Impact You Will Make
​​The Global Leader, Quality Control (QC) Processes and Programs is responsible for establishing, harmonizing, and advancing global QC systems, processes, and standards across all sites within the Kindeva network. This role provides strategic and technical leadership to drive excellence in laboratory operations, data integrity, analytical systems management, method lifecycle control, and regulatory compliance. The position ensures alignment and integration with the enterprise Quality Management System (QMS) and continuous improvement roadmap
Role Responsibilities
• Provide leadership and direction for QA
• Develop and implement a unified global QC process framework that standardizes laboratory practices, data management, and analytical controls across all sites.
• Partner with site QC, QA, and Operations leaders to align on harmonized procedures, metrics, and performance expectations.
• Establish global governance for method lifecycle management, stability programs, analytical transfers, and reference standard management.
• Define and oversee KPIs for QC performance, including RFT, OOT/OOS trends, data integrity metrics, and turnaround times.
• Serve as the global business process owner for QC electronic systems including LIMS, and eQMS-related QC modules (OOS/OOT).
• Drive harmonization of system configuration, master data, and user workflows to ensure global standardization.
• Champion data integrity by design, embedding ALCOA+ principles and risk-based control strategies across analytical data flows.
• Collaborate with IT and validation teams to ensure system lifecycle compliance with 21 CFR Part 11, Annex 11, and GAMP 5.
• Embed Lean Lab, visual management, and right-first-time principles across QC operations.
• Lead global initiatives to streamline analytical processes, reduce cycle time, and improve throughput without compromising quality.
• Benchmark and implement industry best practices for laboratory digitization, automation, and efficiency.
• Mentor site QC leaders and teams to develop a high-performance culture emphasizing accountability, compliance, and innovation.

Basic Qualifications
• Bachelor’s or advanced degree in Chemistry, Biochemistry, Microbiology, or related scientific field or comparable experience.
• 10+ years of progressive experience in Quality Control or Analytical Sciences within GMP manufacturing within a contract manufacturing, contract test lab, or other high volume laboratory (sterile injectables and/or combination products preferred).
• Deep understanding of ICH Q2(R2), Q14, FDA, EMA, and Annex 1 requirements.
• Proven success in harmonizing laboratory systems and processes across multiple regions.
• Experience as system owner or business process owner for LIMS or equivalent digital QC platforms.
• Strong analytical, communication, and influencing skills, with the ability to drive alignment across global and site-based teams.


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Equal Opportunity Employer:


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