External Quality Lead (Senior Manager/Associate Director, commensurate with experience)

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.

Responsibilities

• 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%)

Qualifications

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

• 6–8 years of experience in Quality Assurance, with at least 3 years supporting Sterile Manufacturing

• Minimum of 3-5 years of pharmaceutical quality operations experience or quality oversight of a CMO

• Strong knowledge of cGMP, FDA, and/or EU regulations and requirements

• Experience working in a Global capacity (I,e, interacting with international third parties)

• Strong interpersonal skills including ability to communicate effectively with people individually and in groups; ability to communicate with technical and non-technical colleagues; experience establishing and maintaining effective relationships with leaders and peers

• Ability to lead and participate on teams with shared responsibility for outcomes and decision-making

• Experience with cGMP computer system validation (CSV) and electronic data management

• Prior experience working within SAP, Veeva, and/or Trackwise would be beneficial

Please note: this position is classified as a corporate office position. In accordance with the New York employer convenience rule, Stemline will withhold New York state income taxes for all corporate office employees, regardless of whether these employees work in New York or remotely.

Base Salary Range of $140,000-180,000. Menarini Stemline offers generous compensation and benefits packages, including Short- and Long-Term Incentive Programs, Fidelity 401(k) (with company match), Anthem Premier PPO and HDHP insurance plans, Company paid Basic Life & AD&D insurance and pre-tax FSA/HSA programs.

Menarini Stemline is committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

The Company

Founded in 1886 in Naples under the name of Farmacia Internazionale, Menarini moved in 1915 to Florence where the Group’s headquarters are still located today. High quality therapeutics and diagnostics solutions for patients, ethics as our underlying principle, dedication to innovation and advancement, strong people centricity and environmental sustainability. These five pillars form the foundation of the Menarini Group, an Italian pharmaceutical company with nearly 135 years of history.

The Menarini Group is present in 70 countries and our products are sold in 140 locations around the world. Its companies span from Europe to Asia, to Africa and the Middle East, to Central America and to the United States where with the acquisition of Stemline Therapeutics, a NASDAQ-listed biopharmaceutical company, the company marked its entry into the US oncology market.

Thanks to the valuable contribution of around 18,000 employees, every year more than 500 million packs of drugs are produced at the Group's 18 manufacturing sites including a biotech plant for the manufacturing of monoclonal antibodies that also serves external clients distributed across 6 continents.

Menarini has made a strong commitment to oncology, investing in a pipeline of five investigational compounds for the treatment of a variety of haematological and solid tumours. The acquisition of Stemline Therapeutics in June 2020, further strengthened Menarini’s oncology portfolio, adding both commercial and clinical-stage assets. Tagraxofusp is a novel, first in class targeted therapy for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) and to date, the only approved treatment for BPDCN in the U.S. and EU, and the first and only approved CD123-targeted therapy. Tagraxofusp is also being evaluated as both a single agent and in combination, in other CD123+ indications, including acute myeloid leukaemia (AML), chronic myelomonocytic leukaemia (CMML), and myelofibrosis (MF).

Additionally, Menarini received exclusive rights to commercialise Selinexor for the treatment of oncology indications in the European Union and other European countries (including the United Kingdom), Latin America and other key countries. Menarini has signed an exclusive licensing agreement with Karyopharm Therapeutics for the rights to commercialise an innovative therapeutic option in Europe, Latin America, Turkey, Russia, and CIS countries. Selinexor is a first-in-class, oral Selective Inhibitor of Nuclear export compound for the treatment of hematologic cancers and solid tumours. It is already marketed in the US for multiple myeloma and is under development for solid tumour indications. Selinexor is registered in the EU for both early and late lines.

Menarini entered into a global licence agreement with Radius Health to complete the development of Elacestrant, an oral SERD in late-stage Phase 3 development for hormone receptor-positive advanced breast cancer. Following a successful phase 3 study, Menarini Stemline received FDA approval in January 2023 under priority review and successfully oversaw a strong launch in February to the US market with the EMA review process concluded positively in September 2023.

It is an exciting time in the company’s development and an excellent opportunity for individuals joining us to contribute to building and shaping Menarini Stemline’s Oncology business.