Supply Chain Specialist 3, Compliance
About The Position
The Supply Chain Specialist 3, Compliance is responsible for actions, processes, and audit readiness. This role supports all Supply Chain operations, procedures, systems, processes, and GXP related matters in accordance with the GXP requirements. The SC Specialist 3, Compliance initiates and investigates internal and external exceptions impacting Supply Chain. This role leads the implementation of comprehensive corrective and preventative actions (CAPA) to drive improvements, coordinating vendor change notifications, raw material enrollment and supplier complaints. This role coordinates and is responsible for leading internal and external changes impacting Supply Chain planning, master data, warehouse and logistics, and customer requirements. The SC Specialist, Compliance will be coordinating change management record (CMR) for new raw material enrollment, supplier complaints and vendor change notifications.
Requirements
- High School or GED and 9+ years of relevant work experience
- Bachelor’s degree in Supply Chain, Engineering, Information Science, Data Management, or Life Science related field with 5+ years relevant work experience
Nice To Haves
- Master’s degree in Supply Chain, Engineering, Information Science, Data Management, or Life Science related field with 3+ years of relevant work experience
- Experience in quality management systems (e.g., SAP S4/HANA, Trackwise, Veeva)
- Experience with GMP regulations, audits with FDA or similar organization management
Responsibilities
- Creates, revises, and maintains current Standard Operating Procedures (SOPs), work instructions, training compliance standards, and applicable documentation to support the Supply Chain organization
- Leads optimization projects to ensure continuous process improvements and development for the organization and/or client
- Manages the analysis, revision, and resolution for master data issues, including inventory, SAP processes, cycle counting and other processes within the Supply Chain function
- Manages, performs, initiates, or supports change management records, investigations, corrective and preventive actions (CAPAs), and continuous improvement activities for Drug Substance and Drug Product
- Leads complex investigations when needed and drives actions through cross functional team
- Engages in teams to update SOPs, implement CAPAs, perform investigations and lead these, as needed
- Creates or revises SOPs and/or Work Instructions to support all Supply Chain Operations and functions
- Leads and supports implementation and maintaining the Vendor Change Notification, Supplier Complaint, and Material Enrollment processes
- Coordinates and leads teams within multiple functions and participate in projects/initiatives for Supply Chain support (e.g., SAP, Warehouse, Shipping/Logistics, Master Data, Weigh Dispense and Raw Material Sampling)
- Collaborates with cross functional teams and subject matter experts (SMEs) for assessment and necessary actions to meet schedules, compliance actions, or project initiatives
- Ensures data integrity and compliance for operations and audit readiness
- Performs other duties, as assigned
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
