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MENARINI Group · 6 hours ago

Head of Stemline Quality Operations (Executive Director)

US-NY-New York

Full-time

Onsite

Director/Executive

$292K/yr - $335K/yr

20+ years exp

MENARINI Group is an Italian pharmaceutical company committed to creating innovative therapeutics and diagnostics solutions. The Head of Stemline Quality Operations is responsible for overseeing the implementation and maintenance of Good Manufacturing Practice (GMP) Quality Management Systems, ensuring compliance with global regulatory requirements, and managing quality operations across various functions.

BiotechnologyMedicalPharmaceutical

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

GMP Quality Management SystemsQuality Assurance (QA)Quality Control (QC)Regulatory ComplianceRisk-based ApproachBudget ManagementTraining in GMPsDocument ControlInterpersonal SkillsTeam-oriented

Required

Bachelor's degree in chemistry, biology, pharmaceutical science, or a related scientific discipline

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

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

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