Head of Stemline Quality Operations; Executive Director

Overview

Executive Director, Head of Stemline Quality Operations

The Head of Stemline Quality Operations is responsible for developing, planning, monitoring, and controlling the implementation and maintenance of Stemline Operations’ Good Manufacturing Practice (GMP) Quality Management Systems (QMS) for commercial assets. This role provides comprehensive strategic and operational oversight for Quality Assurance (QA), Quality Control (QC), Quality Systems, Stability Program functions, and the International Quality Affairs function. Given Stemline’s virtual operating model, a critical focus is ensuring appropriate and effective quality oversight of Contract Manufacturing Organizations (CMOs) for drug substance and drug product, as well as third-party vendors responsible for 3PL, storage, and distribution.

The Head of Quality Operations ensures all GMP operations are in compliance with current global regulatory requirements, including FDA, EMA, and other governmental regulatory agencies.

• Quality Leadership and Management
  • Direct, monitor, maintain, and improve all aspects of the Stemline Quality Operations function, including QA, QC, and GMP Quality Management Systems.
  • Build, develop, and train a skilled staff, setting clear standards of performance and ensuring robust evaluation of performance.
  • Manage the departmental budget and expenses.
  • Drive a robust quality culture and ensure personnel have clear expectations and tools to succeed.
  • Ensure regular cadence of Quality Operations staff meetings to review progress on Quality initiatives and issues.
  • Ensure adequate stakeholder engagement and communication, including regular communication with Stemline Operations, Menarini Technical Operations, Menarini Global Quality and other key stakeholders within the Menarini Group of companies.
  • Communicate the status of any significant or critical QA/QC and cGMP activities throughout Stemline to senior management and ensure that timely Quality Management Reviews are conducted.
  • Provide Quality Technical Agreement (QTA) approval, internal audit review/approval, and act as the quality final approver for critical change controls.

• Manufacturing and Supply Chain Quality Oversight (CMOs, 3PL, and Distribution)
  • Ensure appropriate oversight of CMOs who are responsible for the manufacture of drug substance and drug product, providing quality oversight of GMP compliance at manufacturing, packaging, testing, storage, and shipment facilities/CSPs.
  • Lead the GMP batch review, disposition, CMO deviation, and change management programs for API, drug product, and finished goods, ensuring that a risk proportionate approach is defined for appropriate QA / QC oversight for each CMO.
  • Oversee all product disposition functions, ensuring all products (US & ROW) shipped to the marketplace comply with all appropriate quality standards, and taking appropriate action to reject, recall, or withdraw products if necessary.
  • Direct the Supplier Quality Management Program, including managing the annual audit schedule, and timely approval of audit reports. Partner with Global Quality audit team to leverage resources as appropriate.
  • Manage Quality Agreements, including updates, for all vendors and contract service providers.
  • Ensure adequate and compliant investigations are conducted into deviations, OOS/OOT results, and product quality complaints generated both internally and at contract test labs.
  • Oversee the Quality Control function, including the annual stability program, release testing, trending of data, and method validation.

• International Quality, Distribution, and MAH Management
  • Ensure appropriate oversight of the International Quality Affairs function, which serves as the QA Point of Contact for the Legal Entity Program (e.g., BV, GmbH, UK, and IL).
  • Oversee interactions with Marketing Authorization Holders (MAHs) to ensure the necessary licenses and distribution agreements are in place to market drugs in global territories.
  • Provide QA support for International Distributors and 3PLs, including oversight of distribution centers via Qualified Persons (QPs) and Responsible Persons (RPs).
  • Manage and provide support for QP/RPs, ensuring they fulfill responsibilities such as product release, return to stock, and importation oversight.
  • Ensure that processes are in place for the International Quality Affairs team to manage the QMS for affiliates, including approving and processing deviations, CAPAs, Change Controls, and Complaints related to international operations.
  • Provide support for international regulatory submissions.

• Quality Systems and Compliance
  • Ensure that appropriate systems are maintained for training employees in GMPs and company SOPs, ensuring appropriate document control, implementing CAPA, and monitoring stability.
  • Review results of internal audits and supplier/CSP audits to ensure cGMP compliance and appropriate resolution of observations.
  • Oversee the generation of all vendor documents required to draft the Stemline Annual Product Review…