Rose Spear Email & Phone Number

Switzerland 🇨🇭 , Ch

Responsible for ensuring that Roche Diabetes Care is complying to chemical and materialregulations such as REACH and RoHS, as well as initiating further steps in case any substances ofvery high concern are found in products. Ensures that Roche Diabetes Care continues to meet therequirements of product compliance and country specific requirements.* First point of contact for supplier queries regarding compliance issues* Responsible for keeping up-to-date with regulatory requirements in the field* Participation in global networks regarding chemical/material regulations* Maintenance of List of Standard Requirements regarding product compliance* Collaboration in cross-functional teams in order to achieve full material declaration of RDC products as well as support in the pursuit for product stewardship* Evaluation of certificates and further supplier information according to MatCom-related regulatory requirements (e.g. REACH, RoHS, MDR/IVDR)* Initiation of further steps, e.g. in case DG or SVHC are found in products (SCIP registration, SVHC declaration, etc.)* Support in audits, both preparation and in the back office

Switzerland 🇨🇭 , Ch

Develops, implements and maintains the quality system for the assigned business areas/locations to meet Roche corporate standards, the requirements of applicable health authorities and other regulatory agencies. Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance. Ensures quality systems described in policies and procedures are linked to business processes. Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines.• PLM Indy process lead for the IVDR.MDR project.• Prepares and/or revises departmental procedures within Windchill.• Participates on cross-functional project teams to provide documentation and distribution expertise. • Collaborates on complex changes and provides guidance and understanding to users to process changes through the system quickly and efficiently. • Reviews and ensures that change requests and change notices move through the system accurately and efficiently.• Experienced in Windchill and SAP applications PDC, P08 and MDG-M

Switzerland 🇨🇭 , Ch

Responsible for quality and governance activities required for all Regional and Global master data. Has ownership in developing master data templates and data quality governance activities for Roche Diabetes Care. Prepares and revises documentation in WindChill to ensure compliance with the Quality System Regulations and regulatory guidelines.• Co-managed the project to create baselining for Device Master Records in Windchill. This process will enhance the accuracy and ease of reporting of Device Master Records to the FDA.• Analyzed the impact of Windchill and SAP material master data changes for traceability, auditability and accuracy. • Evaluated SAP master data for accuracy and implemented strategies to correct errors for SAP data processes.• Consulted with internal and external business partners by providing recommendations to enhance collection, integrity and strengths of their data sets.• Evaluated Quality SOPs concerning SAP standards and suggested revisions to reflect existing and global practices. • Assisted with the onboarding of new employees to ensure they have access to essential programs for training.• Trained as a Change Coordinator for PLM Engineering Group

Provide logistics and business planning groups with equipment, resource, and cost analysis support to reduce logistics costs and optimize utilization while ensuring that customer expectations are met. Accountable for continuous process improvements and maintaining process maps and documents needed to comply with Trade Compliance, ISO 9000, Responsible Care, and other designated programs. Establish procedures for collecting data needed to monitor trends in logistics costs, analyze impact, conduct competitive analysis, and recommend course of action based on analysis.• Implemented global process for trade compliance, including Letter of Credit, FTA, commodity code, and country of origin, reducing risk of audit finds.• Designed robust, user-friendly trade compliance program that was easy to update, documenting historical trail for reference, including US and European commodity codes, country of origin, and free trade agreements.• Created standard practices for 12 US warehouse locations, such as training manuals for SAP, load configuration, shipping documentation, inventory reconciliation, and ISO documentation. Achieved 100% inventory accuracy at all US warehouses and accountability at all sites.• Vetted and delivered training at seven 3rd-party warehouses, ensuring all had capability to store and ship hazardous materials for complex international supply chain.• Arranged tax-deductible donation of $48K of raw packaging supplies to Gleaners Food Bank, avoiding cost of disposal of unneeded supplies or storage.• Negotiated new lease for fleet of specialized ISO containers, reducing yearly cost by $109K.

Identified and analyzed company’s sales and service opportunities. Developed pricing strategies that aligned business and service to competitors. Business was sold in 2008.• Implemented 12% price increase between 2006 and 2007, increasing S&OP to $1.3M gross margin in 2007.• Improved sales margin by implementing 13% price increase between 2005 and 2006.• Implemented contractual agreements requiring customers to take minimum and maximum quantities, enhancing ability of master production schedulers to improve on-time delivery.• Located and contracted new carrier more centrally located, saving close to $1M in transit costs.

Managed of month-end closing procedures for sales. Maintained customer master data records.• Performed data reconciliation, ensuring inventory record accuracy.• Communicated with service suppliers, ensuring timeliness and accuracy.• Generated reports for tolling and logistics partners.• Served as SAP Super User for shipping, deliveries, and sales.

• Master Production Scheduler• Customer Service Representative• Shipping Clerk (Union) & 1999 – 2000 SAP Assistant trainer• Packaging and Warehousing (Union)