Manager - Warehouse Quality Systems
BioSpace · New Albany, OH · 3 wk ago
Quality AssuranceFull-time
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
- Influence a broad spectrum of partners toward achieving business goals
Qualifications
- Doctorate degree
- Masters degree and 2 years of Supply Chain experience
- Bachelors degree and 4 years of Supply Chain experience
- Associates degree and 8 years of Supply Chain experience
- 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