Dora Kohlhauf

About Dora Kohlhauf

Professional SummaryStrategic and results-driven Senior Manager with extensive experience leading Compliance, Documentation, and Training operations within a global supply chain environment. Proven ability to drive quality, regulatory compliance, and operational excellence through innovative training programs, robust document management systems, and cross-functional collaboration. Adept at leading high-performing teams, managing complex projects, and aligning initiatives with enterprise-wide strategies to enhance organizational effectiveness and regulatory readiness.

Experience

1. Sr Manager, Global Supply Chain Strategic Capabilities - Gsc Transformation

   Bristol-Myers Squibb

   Oct 2024 — Present · US

   Strategic & results-driven leader with extensive experience in Compliance, Documentation, & Training operations within global supply chain environments. Recognized for driving quality, regulatory compliance, & operational excellence through innovative learning programs, robust document management systems, & enterprise-level initiatives. Adept at leading high-performing teams, managing complex projects, aligning strategies with organizational goals to enhance effectiveness & readiness.LEADERSHIP HIGHLIGHTSCompliance Leadership: Primary point of contact for audits and inspections, ensuring readiness and adherence to GxP standards.Global Process Owner: Governance and rollout for eDMS and LMS systems across Global Supply Chain.Change Champion: Led enterprise-level initiatives including BMSDocs implementation and GxP training simplification.Operational Excellence: Developed tracking tools and optimized processes for workload planning and resource allocation.PROFESSIONAL EXPERIENCE• Lead Document and Training functions across GSC pillars and locations, ensuring compliance and efficiency.• Manage team of Compliance Managers, Document Managers, Technical Writers, and Training Specialists.• Act as point of contact for internal and regulatory audits and inspections.• Serve as Local Process Owner for eDMS and LMS systems, overseeing governance and rollout.• Develop and maintain master document listings and GxP periodic review schedules.• Provide compliance metrics and analytics to leadership and Global Quality teams.• Champion enterprise initiatives including Learning Management System implementation and centralization. Optimize translation and stakeholder management processes, including Service Level Agreement and budget planning.• Identify and implement innovative instructional technologies and delivery methods to enhance training efficiency.• Supported Investigational Product returns process and Sunshine Act compliance reporting.• Managed TMF documentation.