Supply Chain Quality Senior Manager

Our Company

NeoImmuneTech, Inc. (NIT) is a clinical-stage T cell-focused biopharmaceutical company dedicated to expanding the horizon of immuno-oncology and enhancing immunity to infectious diseases. NIT is led by the scientific founder and inventor of NT-I7 (efineptakin alfa) and has a strong executive team with rich industry experience.

We Offer

• Competitive pay
• 401(k) company matching - 100% vests immediately!
• Medical insurance
• Flexible Spending Account (FSA)
• Life insurance
• Paid Time Off
• Paid holidays
• Paid family medical leave
• Cell phone reimbursement
• Internet reimbursement

Job Summary

The Supply Chain Quality Senior Manager will support pharmaceutical distribution activities for prescription drug products, ensuring compliance with Maryland Board of Pharmacy wholesale distributor licensure, FDA regulations, DSCSA, GDP, and internal quality standards. This role will serve as the Immediate Supervisor of the Designated Representative overseeing compliant distribution, storage, recordkeeping, and facility operations.

Responsibilities

• Support compliant pharmaceutical distribution activities including receipt, storage, handling, and shipment of prescription drug products
• Ensure compliance with Maryland Board of Pharmacy wholesale distributor requirements, COMAR, FDA, DSCSA, and GDP requirements
• Maintain distribution records including transaction history, chain of custody, inventory, returns, complaints, and destruction documentation in accordance with applicable record retention requirements
• Oversee environmental/temperature monitoring, facility controls, and security requirements including access controls and alarm response
• Develop and maintain written policies, SOPs, procedures, and documentation required for wholesale distribution and the supporting quality system
• Train personnel in warehouse/distribution activities and regulatory requirements and maintain training documentation
• Oversee and coordinate with logistics partners, transporters, and third-party distribution vendors to ensure compliant distribution activities
• Investigate and document distribution-related events such as complaints, deviations, returns, and temperature excursions, including escalation and CAPA as required
• Maintain inspection readiness and act as the point of contact for internal/external audits and regulatory inspections, including coordination of responses to observations
• Maintain qualification and eligibility to serve as the company’s Immediate Supervisor under Maryland Board of Pharmacy requirements, including completion of any required renewals

Qualifications

• Bachelor’s degree in pharmacy, pharmaceutical sciences, supply chain, engineering, or related discipline
• Minimum of 3 years of hands-on experience in pharmaceutical distribution, supply chain QA, warehouse QA, logistics, or regulated pharmaceutical operations
• Experience in GMP/GDP operations including storage, handling, and distribution of medicinal products
• Experience in writing, reviewing, or implementing SOPs, controlled documents, and quality procedures
• Experience supporting regulatory inspections, audits, or GDP compliance programs
• Knowledge of DSCSA, FDA guidance on pharmaceutical distribution, and/or state Board of Pharmacy requirements applicable to wholesale distribution
• Understanding of controlled access, chain of custody, temperature-controlled distribution, and warehouse quality practices
• Strong documentation, recordkeeping, and QA oriented skillset
• Ability to collaborate cross-functionally with QA, Regulatory, Supply Chain, and 3PL vendors
• Ability to meet and maintain Maryland Board of Pharmacy Immediate Supervisor eligibility requirements

NeoImmuneTech, Inc. provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

If you require assistance to complete a job application, please email us at hr-us@neoimmunetech.com. 

Salary : $100,000 - $130,000