Overview

Executive Director, Head of Stemline Quality Operations

Reports to VP, Head of Global R&D Quality; Stemline Quality Operations

Opportunity

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.

Responsibilities

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 (APR)/Product Quality Reports (PQR) and ensure final review of these documents.
• Direct and monitor all quality and regulatory compliance matters, maintaining current knowledge of global regulations (FDA, EMA, 21 CFR 210/211, ICH Guidelines).
• Submit FARs, BPDRs, to US FDA, if required.
• Represent Stemline Inc. during inspections and visits by FDA, EMA, other governmental regulatory agencies, and customers, ensuring responses to observations (e.g., FDA 483s) are drafted and resolved appropriately.

Qualifications

• Education: Bachelor's degree in chemistry, biology, pharmaceutical science, or a related scientific discipline; advanced degree preferred.
• Experience: 20+ years of related experience, preferably in life sciences, with a minimum of fifteen years of management experience in Quality Assurance/Quality Control operations within commercial and development programs. Experience as Quality Lead in a Global External supply organization is preferred even if not mandatory.
• Regulatory Expertise: Strong working knowledge and expertise in US FDA regulations, EMA regulations, cGMPs, and ICH Guidelines. Direct experience with hosting, leading, and managing US and international regulatory agency inspections is required.
• Skills: Proven ability to manage shifting priorities and resolve Quality issues/discrepancies through a risk-based approach. Demonstrated strength in quality oversight of GMP operations and strong interpersonal skills for interfacing with agencies and contract service providers. Must be extremely collaborative and team-oriented in all interfaces across the Company.

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 $291,947-$335,008. 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.

Menarini's commitment to oncology is also reflected in the investments made in the liquid biopsy diagnostic field through its affiliate Menarini Silicon Biosystems (MSB), a pioneer in rare cell analysis and non-invasive, advanced diagnostic solutions. MSB's CELLSEARCH Circulating Tumour Cell (CTC) Test is the first and only clinically validated blood test cleared by the U.S. Food & Drug Administration (FDA) for detecting and counting CTCs in metastatic breast, prostate, and colorectal cancer when used in conjunction with other clinical monitoring methods.

Since 2021, MSB has offered in the US a menu of non-invasive Laboratory Developed Tests (LDTs) provided through its CLIA/CAP accredited US-based Lab. The services include CMC enumeration, CTC enumeration and PDL-1/HER2 biomarker and offer a minimally invasive approach to follow cancer patient's therapeutic journey.

In 2022, the company launched the CELLSEARCH® Circulating Multiple Myeloma Cell (CMMC) Enumeration LDT, the first-of-its-kind, which directly measures levels of plasma cells in the blood of patients. This test provides new, complementary information to that of the bone marrow biopsy and other standard-of-care measures. Due to its minimally invasive nature, it can be performed serially to assess plasma cell burden without requiring repeated bone marrow biopsies.

Menarini's vision and uniqueness in oncology is to bring together innovative therapeutic solutions and advanced liquid biopsy-based diagnostics for faster, more effective and precise patient management.

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.