Menarini Stemline · 7 hours ago
Head of Stemline Quality Operations (Executive Director)
New York, NY
Full-time
Onsite
Director/Executive
$292K/yr - $335K/yr
20+ years expMenarini Stemline is a pharmaceutical company focused on oncology solutions, and they are seeking an Executive Director for Stemline Quality Operations. This role involves overseeing the implementation and maintenance of Good Manufacturing Practice (GMP) Quality Management Systems and ensuring compliance with global regulatory requirements.
BiotechnologyHealth CareHealth DiagnosticsOncology
Responsibilities
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
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
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
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
Qualification
Required
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
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
Preferred
Experience as Quality Lead in a Global External supply organization is preferred even if not mandatory
Benefits
Generous compensation and benefits packages
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
Pre-tax FSA/HSA programs
Company
Menarini Stemline
The Menarini Group ("Menarini"), a leading Italian pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc.
501-1000 employees
H1B Sponsorship
Menarini Stemline has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (3)
2023 (2)
2022 (2)
Funding
Current Stage
Public CompanyTotal Funding
$195.09MKey Investors
Pequot Capital
2020-05-04Acquired
2019-08-01Post Ipo Equity· $88M
2019-01-15Post Ipo Equity· $92M
Leadership Team
David Gionco
Vice President of Finance and Chief Accounting Officer
Ahmed Rabie
Chief Commercial Officer
Recent News
2025-10-13
2025-09-27
Company data provided by crunchbase