What You'll Do: • Works in collaboration with customers and stakeholders from QC, Drug Substance Manufacturing (DSM), and Drug Product (DP) fill/finish to support tech transfers of new customer projects as they relate to QC Sample Plans, Stability studies, and DS/DP Specifications• Authors, reviews, and leads updates of controlled GMP documents related to QC Sample Plans, QC Specifications, Stability protocols, reports, and stability specifications• Leads, authors, and reviews change controls of QC Sample Plans and stability protocols for both internal and external changes together with relevant stakeholders, including communication with customers as applicable• Manages and directs the continuous improvement of QC Sample Plans and QC Specifications• Applies a holistic quality system approach through identifying and solving technical compliance gaps and areas for improvement or remediation related to quality or process; leads through completion and sustainable implementation• Leads/participates in team compliance activities including writing, changing, and maintaining GMP documents in collaboration with relevant stakeholders and QA• Ensures compliance with platform, procedures, and global QC vision• Supports management in training compliance with policies and inspections• Supports regulatory requests, audits, and inspections• Collaborates with the Laboratory Information Management System (LIMS) team and IT department to build DS/DP sample plan, specification, and stability functions that meet end-user and customer requirements• Provides guidance and feedback for QC personnel development• Performs other duties as assigned. Preferred Requirements: • 5+ years of project management experience in biotechnology, Pharma, Contract Research Organization (CRO), or Contract Laboratory Organization (CLO)• Experience with Customer Relationship Management• Drug substance or manufacturing experience, including process validation, transfer, commercialization, and manufacturing support and troubleshooting• Experience using quality systems (e.g., deviation management system, change control, corrective and preventive action (CAPA), document management system).