Sr. Manager/Associate Director, Quality Control

Reporting to the Director of Quality Control, you will lead the tactical execution and day-to-day quality control oversight of our oncology product portfolio, ensuring all commercially manufactured products, clinical trial assets, and stability samples meet rigorous safety and efficacy standards.

Responsibilities

• Operational Oversight & CMO Coordination
  • 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.
  • Review and approve laboratory data (including release testing of components, raw materials, intermediates, finished product, validation, and stability) and investigations (OOS, OOT, Atypical, and product complaints), ensuring timely resolution and data integrity.
  • 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
  • Perform detailed review and approval of method validation protocols/reports, analytical test methods, specifications, and SOPs to ensure alignment with cGMP, compendial requirements, CFR, and company policies.
  • Develop and track laboratory analysis metrics to monitor site performance and identify areas for continuous improvement.
  • 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
  • Partner with R&D CMC to oversee the quality control aspects of new drug development and clinical/commercial supply.

Requirements

• 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.
• Strong knowledge of cGMP, FDA, and CHMP/EU regulations.
• Up to 5% travel may be required for CMO site visits/audits and in-person meetings at the corporate office in NYC.

This position is classified as a corporate office role. 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 work location.

Pay

Base Salary Range of $140,000 - $200,000 plus annual bonus and long-term incentives.

Benefits

• 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.