The Supply Chain Compliance Specialist 2 is responsible for actions, processes, and audit readiness at FDBN. This role supports all Supply Chain operations, procedures, systems, processes, and GXP related matters in accordance with the GXP requirements defined in the Pharmaceutical Quality System. Support includes initiation and investigation of internal and external exceptions impacting Supply Chain, supporting the establishment, and implementation of comprehensive corrective and preventative actions to prevent recurrence and drive improvements. This role coordinates internal and external changes impacting Supply Chain planning, master data, warehouse and logistics, and customer requirements.

Major Accountabilities

Creates, revises, and maintains current Standard Operating Procedures (SOPs), work instructions, training compliance standards, and applicable documentation to support the Supply Chain organization
• Supports optimization projects to ensure continuous process improvements and development for the organization and/or client
• Supports the analysis, revision, and resolution for master data issues, including inventory, SAP processes, cycle counting and other processes within the Supply Chain function
• Performs, initiates, and supports change management records, investigations, CAPAs, 3C and CI activities for Drug Substance and Drug Product
• Works in multiple functions and participates in projects/initiatives for Supply Chain support; including SAP, Warehouse, Shipping/Logistics, Master Data, Weigh and Dispense, and Raw Material Sampling
• investigations updates SOPs, implements CAPAs, performs investigations, as needed
• Collaborates with cross functional teams and subject matter experts (SMEs) for assessment and necessary actions to meet schedules, compliance actions, or project initiatives
• Plans, facilitates, and coordinates with SMEs, Quality, Manufacturing, Process Science, and Customers to ensure changes are implemented compliantly within defined timelines and documented in the appropriate quality system.
• Ensures data integrity and compliance for operations and audit readiness

Minimum Requirements

• High School Diploma/GED with 4 years of previous work experience in Supply Chain -OR-
• Bachelor's degree with 2 years of previous work experience in Supply Chain

Preferred Requirements

• 3+ years of relevant work experience
• SAP S4/HANA or other SAP ERP system experience
• GMP regulation experience
• Audits with FDA or similar organization management
• Advanced Excel skills