Manager, Global Stability
As the Manager, Global Stability, you will serve as the strategic leader and accountable owner of Colgate-Palmolive's global product stability program, sitting within the Global Quality organization. This high-impact role offers an exciting opportunity to drive regulatory compliance, technical excellence, and data integrity across all Manufacturing Sites and Global Technology Centers worldwide. Your primary mission will be to ensure robust compliance with global regulations and ICH guidelines while leading the continuous digital evolution of our stability data frameworks.
Responsibilities:
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Define and execute the global stability strategy to guarantee continuous compliance with all applicable global regulations, ICH guidelines, and internal Quality Standards
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Oversee and approve stability protocols, studies, data, and technical documentation prepared for submission to external regulatory agencies
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Partner cross-functionally with key collaborators across the R&D community, Manufacturing Sites, and Global Technology Centers to provide technical guidance and troubleshoot global program issues
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Drive robust investigations into stability OOS/OOT results, ensuring rigorous root cause analysis, sound scientific conclusions, and effective CAPAs
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Lead the digital governance and global enhancement of LIMS stability modules and analytics dashboards to monitor compliance, program metrics, and chamber capacity
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Serve as the primary Subject Matter Expert (SME) during internal and external regulatory inspections, while leading the internal Stability Community of Practice to scale organizational knowledge
Required Qualifications:
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Bachelor’s Degree in Engineering, Chemistry, or a related Biological Science field
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At least 8 years of experience in a cGMP regulated environment
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Experience leading multi-category Stability programs and Quality Systems
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In depth technical knowledge of cGMP, FDA regulations, 21 CFR 210 & 211, and ICH guidelines
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Demonstrated project management experience managing regulatory documentation or data-driven technical programs
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Deep technical skills in validation concepts, statistical trend analysis, and quality-related systems such as LIMS, LabNet, and ETQ
Preferred Qualifications:
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Master’s Degree in Engineering, Chemistry, or a related Biological Science field
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Advanced expertise in Root Cause Analysis methodologies for OOS/OOT results
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Strong alignment with internal LIFT leadership principles including exceptional cross-functional collaboration and communication skills
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Demonstrated expertise in leveraging data to influence decision making