External Quality Lead; Senior Manager​/Associate Director, commensurate

Overview

External Quality Lead

Reports to Director Product Quality Lead

The External Quality Lead (EQL) provides the tactical, "day-to-day" Quality oversight of our external manufacturing partners (CMOs) within Menarini Stemline's virtual operating model. In addition to managing commercial batch disposition, this role, working with the Product Quality Lead, ensures quality oversight for all product phases (clinical to commercial) and is critical for compliance with cGMP regulations and Menarini Stemline's quality systems.

Key responsibilities include ensuring adherence to cGMP in processes such as batch production, product release, laboratory testing, investigations/CAPA, Change Control, Annual Product Reviews, and Product Quality Complaint handling.

Overview

Sr. Manager/ Associate Director
External Quality Lead

Reports to Director Product Quality Lead

The External Quality Lead (EQL) provides the tactical, "day-to-day" Quality oversight of our external manufacturing partners (CMOs) within Menarini Stemline's virtual operating model. In addition to managing commercial batch disposition, this role, working with the Product Quality Lead, ensures quality oversight for all product phases (clinical to commercial) and is critical for compliance with cGMP regulations and Menarini Stemline's quality systems.

Key responsibilities include ensuring adherence to cGMP in processes such as batch production, product release, laboratory testing, investigations/CAPA, Change Control, Annual Product Reviews, and Product Quality Complaint handling.

• Tech Transfer Execution:
  Collaborate closely with the relevant organization (e.g. R&D or CMO) during any technology transfer to ensure CMOs achieve appropriate readiness to move to commercialization.
• Validation & Stability Handoff:
  Align with R&D and Quality Control on touchpoints for the management of the stability Quality Control program. Review and approve process validation, analytical method transfer, and equipment qualification protocols/reports.
• Operational Oversight:
  Provide operational QA oversight for products manufactured at CMOs or at Menarini manufacturing sites, ensuring they are in full compliance to manufacture, test, and release commercial products. Ensure establishment, maintenance and adherence to appropriate Quality Agreements.
• Batch Disposition:
  Lead the review and approval of Master Production Records (MPRs) and Executed Production Records (EPRs) for Drug Substance and Drug Product to drive final product disposition.
• Technical Deviation Management:
  Review and approve deviations, OOS/OOT results, and CAPAs generated by the CMO. Ensure robust root-cause analysis and the implementation of effective preventive actions.
• Operational Change Control:
  Review and approve all CMO change controls to accommodate process scale-up and ensure Operations teams generate appropriate Change Controls for process-related changes prior to execution.
• On-Site Oversight:
  Provide Quality oversight of GMP compliance at manufacturing, packaging, and testing facilities. Lead or support CMO audits and execute "Person-in-Plant" activities as required.
• Support the creation and maintenance of appropriate procedural documentation.
• Manage and prioritize workload and projects to ensure effective and efficient completion of tasks, and work independently
• Cultivate and maintain effective working relationships with internal teams, senior leadership, and CMO management
• Act as a bridge between departmental teams and senior leadership, ensuring alignment with corporate goals
• Work with Quality Operations management to support regulatory inspections, FDA, EMA, etc.
• Travel to CMOs as needed (~25%)

• Bachelor’s degree, preferably in a scientific discipline, or comparable…