The Senior Director, GxP Compliance will be responsible for the development, implementation, maintenance and continuous improvement of global Compliance programs to support Global GxP operations and supply within Immunomedics and ensure compliance with relevant regulations.
Manage GMP Training Program, company-wide, and assure that company-wide GMP training is performed in compliance with Current Good Manufacturing Practices, company policies and procedures.
Oversee Administration of the ComplianceWire Learning Management System (LMS) including workflows for user access/ security roles, assignments/ curriculums / user groups, SOP revisions, data entry/ organization, custom fields
The Manager, CMO - Quality Assurance is responsible for managing activities within Quality Assurance for all CMO (Contract Manufacturing Operations). This position also contributes to the completion of routine technical tasks and any additional quality task identified.
Supports QA Leadership in the risk-based Clinical Quality Assurance (CQA) oversight for internal and external process and systems supporting Immunomedics clinical trials. Provides GCP compliance support to Clinical development and operations, including GCP QMS (quality manual, SOPs, WPs, etc.) development/maintenance. Actively contributes to the risk-based GCP audit program, including CAPA, GCP training and inspection readiness. Provides day to day compliance support to Clinical study teams and cross-functionally to other functional areas, e.g., clinical supplies, Regulatory, PV, medical affairs.
Provide Quality assistance and oversight during manufacturing of in-process, upstream and downstream, and other GMP processes as required. Assists in the identification, generation and quality approval of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines.
This is a hands-on role acting as a site subject matter expert on characterization and management of reference standards. Through coordination of in-house and contract laboratories, the QC Scientist – Protein Characterization coordinates the sourcing, manufacture, testing and release of product reference standards for antibody drug conjugate products and product intermediates, provides technical input and manages the supply of product reference standards, ensuring continuity of supply across a global network of in-house and contract GMP testing laboratories. Responsibilities include development of testing protocols, review of batch records, release of test results and control of inventory.