The Role:

ElevateBio is seeking an Associate Director, Quality Assurance, Supplier and Material Quality, responsible for the GxP Supplier Quality and Material Quality programs to ensure cGMP compliance and operational efficiency for clinical early-phase through commercial GMP drug substance and drug product manufacturing, material suppliers and outsourced GxP services at ElevateBio BaseCamp

Here's What You'll Do:

• Responsible for the management, monitoring and continual improvement of the GxP supplier and material management programs in accordance with regulatory requirements, industry standards, customer requirements and internal policies and procedures
• Serve as a Supplier Quality SME for lifecycle management of GxP suppliers and service providers
• Support and collaborate with cross-functional teams for the selection, onboarding and lifecycle management of GxP materials, suppliers and service providers
• Provide tactical direction, process improvement and change management support for internal processes to manage external suppliers and service providers in resolving quality and other technical issues
• Support the development of material specifications, coordination of testing and disposition of GMP raw materials
• Support and collaborate with the Quality Audit program for timely and relevant supplier audits
• Interface with the Supply Chain organization for managing supplier relationships, warehouse materials management and supplier quality notifications
• Interface with the Quality Control Raw Materials team for managing material specifications, risk assessments, material inspections and testing
• Support and collaborate with QA, Technical Operations and Manufacturing teams for lifecycle of specifications, management of material/supplier related Deviations, CAPA, Change Controls, including Non-conforming Material events, Supplier Corrective Action Requests, and other projects related to materials, suppliers, and service providers.

Additionally, will be responsible to:

• Support hosting client audits and regulatory health authority inspections
• Compile and provide operational and quality metrics for periodic Management review.
• Promote a Quality Culture by driving continuous improvement, innovation, teamwork and efficiency.
• Travel may be required up to 25%

Requirements:

• BS in a scientific discipline with 8 years' experience in pharmaceutical / biotech industry within Quality Control or Quality Assurance, at least 2 years managing Supplier Quality topics
• Experience in cell and gene therapy or advanced therapies pharmaceutical industry preferred
• Experience in early and late clinical phase programs preferred
• Experience in CDMO setting preferred
• Knowledge of domestic and international GMP and pharmaceutical regulations
• Ability to communicate effectively and work independently with scientific/technical personnel.
• Strong knowledge of GMP, SOPs, and quality system processes
• Outstanding communication skills (verbal and written)
• Ability to manage multiple projects in a fast-paced environment
• Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.
• Has advanced understanding of the job and applies knowledge and skills to complete a wide range of tasks. Familiar with a variety of the field's concepts, practices, and procedures
• High degree of independence. Requires very limited supervision when acting or making decisions within existing policies and practices. Relies on experience and judgment to plan and accomplish goals