Sr. Manager/Associate Director, Quality Control

Overview

The Sr. Manager/AD Quality Control will lead the tactical execution and day-to-day quality control oversight of our oncology product portfolio. Reporting to the Director of Quality Control, you are responsible for ensuring that all commercially manufactured products, clinical trial assets, and stability samples meet rigorous safety and efficacy standards. You will serve as the primary technical point of contact for our Contract Manufacturing Organization (CMO) partners, managing lab investigations, ensuring all testing is executed within cGMP requirements and Menarini Stemline Procedures and promoting quality principles throughout the organization. You will liaise with internal customers and regulatory agencies and will ensure compliance to Menarini Stemline’s quality systems and current regulations. You will work with the Director of Quality Control to ensure the development and implementation of prevention-based quality awareness and improvement programs are executed appropriately.

Responsibilities

Operational Oversight & CMO Coordination

• Daily CMO Liaison: Act as the primary technical contact for CMOs to ensure full compliance in testing and timely release of products. Support Quality Audits of CMO Laboratories.
• Laboratory Data (including release testing of components, raw materials, intermediates, finished product, validation and stability) and Investigations (OOS, OOT, Atypical, and product complaints): Review and approve laboratory data, investigations (OOS/OOT), and their associated CAPAs, ensuring timely resolution and data integrity.
• Reference Standard Qualifications and & Analytical Test Method Maintenance: Coordinate the Menarini Stemline Reference Standard Program and method revisions via Change Control to ensure CMOs have the most current technical documentation.

Quality Systems Execution

• Technical Document Review: Perform detailed review and approval of method validation protocols/reports, analytical test methods, specifications, and SOPs to ensure they align with current good manufacturing practices, compendial requirements, CFR, and company policies and procedures.
• Metric Tracking: Develop and track laboratory analysis metrics to monitor site performance, identify areas for continuous improvement, and achieve the stated goals and objectives of the business unit.
• Regulatory Support: Participate directly in audit and inspection readiness (FDA, EMA), serving as a technical subject matter expert for laboratory analysis during health authority interactions, regulatory filings, and information requests.

Team & Project Leadership

• Cross-Functional Collaboration: Partner with R&D CMC to oversee the quality control aspects of new drug development and clinical/commercial supply.

Qualifications

• Education: BS Degree in Chemistry, Biology, or related scientific discipline; advanced degree preferred.
• 10+ years in Quality Control within a regulated GMP laboratory environment.
• Minimum of 3-5 years of supervisory or management experience, with a focus on laboratory operations and CMO oversight.
• Regulatory: Strong knowledge of cGMP, FDA, and CHMP/EU regulations.
• Travel: Up to 5% travel may be required for CMO site visits / audits and in-person meetings at the corporate office, NYC.

Please note: This position is classified as a corporate office position. In accordance with the New York state 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 - $200,000 plus annual bonus & long-term Incentives. Menarini Stemline offers generous compensation and benefits packages, including, 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.