Manager - Warehouse Quality Systems

About the role

The Manager, Warehouse Quality Systems at Amgen Advanced Assembly and Final Product Operations in New Albany, Ohio, is a vital role within the Supply Chain team. Reporting to the Senior Manager, this position involves participating in multiple cross-functional initiatives for Amgen Ohio (AOH), leading to the warehouse quality process applying enterprise-wide programs. Responsibilities include ensuring compliance with GMP/GDP and EHSS requirements, owning and providing input for quality systems records, assessing impacts of new requirements, and managing performance on specific KPIs.

Responsibilities

• Ensure compliance with GMP/GDP and EHSS requirements
• Own and/or provide input and support for quality systems records (deviations, change control records, CAPA, CAPA EV, SOP, etc.) or other records
• Acts as Risk Assessment Facilitator or owner
• Assess impact of new requirements, changes, processes, and distribution regulations to the department
• Own and lead change controls for the warehouse
• Own deviation records for the Warehouse
• Participate in revision of controlled documents
• Act as warehouse representative in cross departmental projects
• Act as a point of contact for other departments (e.g. Packaging, QA, Planning, etc.)
• Track performance on specific KPIs
• Participate in network meetings
• Act as delegate for the Senior Manager Supply Chain
• Measure and report on Key Supply Chain Key Performance measures and drive continuous improvement leveraging Amgen standard tools and methods
• Define problem statements, reports, and possible solutions, and present information to Warehouse management for follow-up and/or partner concerns
• Develop solutions to departmental and cross-functional business problems through in-depth analysis, coordination, and negotiation with key decision makers
• Manage sophisticated and ambiguous issues to identify critical factors to enable decision making
• Respond effectively to crises and resolve conflicts arising from competing objectives, limited resources, or differing perspectives
• Contribute to strategic decisions affecting operations
• Perform root cause analysis and implement corrective actions related to associated deviations
• Serve as a role model and mentor, designing opportunities for career development
• Build cross-functional relationships to develop and garner support for shared programs
• Influence a broad spectrum of partners toward achieving business goals

Requirements

• Doctorate degree OR Master’s degree and 2 years of Supply Chain experience OR Bachelor’s degree and 4 years of Supply Chain experience OR Associate’s degree and 8 years of Supply Chain experience OR High school diploma / GED and 10 years of Supply Chain experience
• Quality, Business Administration, Supply Chain & Logistics Management, Manufacturing/Packaging, or Industrial Engineering background
• Good understanding of ERP-SAP, ECC, WM, EWM
• APICS CPIM, CSCP or SCOR-P certified
• 3+ years of Supply Chain Management
• Operational Excellence experience in regulated industry
• Experience with regulated environments (i.e. cGMP, GDP OSHA)
• Proficient user of software applications (Excel, PowerPoint, Smart sheet, Skype, Tableau)
• Leadership and team building skills
• Change management skills
• Good organizational and communications skills
• Excellent written and verbal communication skills
• Continuous improvement mentality
• Experience working in a global environment, ability to collaborate closely/communicate effectively at different management levels
• Availability for international business trips and to support non-standard shift organization with the flexibility to work extended hours
• Knowledge of staff relations with the ability to coach, mentor and counsel staff when needed
• Knowledge of basic compensation system practices and methodologies

Qualifications

• Doctorate degree
• Master’s degree and 2 years of Supply Chain experience
• Bachelor’s degree and 4 years of Supply Chain experience
• Associate’s degree and 8 years of Supply Chain experience
• High school diploma / GED and 10 years of Supply Chain experience