Partner Therapeutics

• The QA Specialist IV External Quality Assurance (ExQA) role is responsible for the overall quality of biologic products and directly involved with CMO oversight of drug substance, sterile drug product and finished product manufacturing. • The individual is responsible for assuring compliance with current good manufacturing practices and regulatory compliance requirements and ensuring products, materials and services are procured, released and monitored via established systems. • Primary Quality point of contact for CMOs. • Ensures timely Quality review/approval of CMO deviations, change controls and batch release requirements and integrates these records into Partner Therapeutics’ (“PTx”) cGMP systems. • Ensures timely Quality review/approval of documents required to support technology transfer. • Responsible for the development, continuous improvement, coordination and ensuring compliance for all Quality aspects of the lifecycle stages of CMO Management. • Acts as a liaison between Quality Assurance, Regulatory, and our CMO partners in providing compliance oversight for regulatory submissions supporting technology transfer/existing CMO production, ensuring timely Quality review/approval of required regulatory documents. • Oversees change control implementations at CMOs, including timely Quality review/approval of documents and coordinating impact assessments from Subject Matter Experts. • Supports PTx Regulatory Intelligence role in the development and implementation of updates affecting CMO operations. • Supports PTx inspection readiness for CMO activities in alignment with good manufacturing practices, regulatory compliance requirements and current industry standards, including inspection walkthrough and preparedness activities, response management, and tracking. • Supports the other departmental responsibilities, including post market surveillance, product quality complaint investigations, and product labeling. • Supports/coordinates cGMP investigations for drug and finished product, CMO deviations, and integration into appropriate PTx Northpointe Quality Systems.

• Provides operational oversight and support for planning, preparation, tracking, publishing, QC, validation, and timely submission of eCTD submissions. • Independently develops regulatory submission documents, ensuring accuracy of content. • Leads and coordinates cross-functional teams during routine right-to-operate submissions. • Ensures applications and dossiers are prepared to the highest quality standards. • Trains and supports internal and external RIM system contributors on author and review processes. • Develops and implements standards for publishing, archiving, metrics, and submission processes. • Manages and indexes archival activities of regulatory submissions.