NeoImmuneTech
Join to apply for the
Supply Chain Quality Senior Manager
role at
NeoImmuneTech
1 day ago Be among the first 25 applicants
Join to apply for the
Supply Chain Quality Senior Manager
role at
NeoImmuneTech
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, record‑keeping, 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, record‑keeping, 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.
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Quality Assurance
#J-18808-Ljbffr
Supply Chain Quality Senior Manager
role at
NeoImmuneTech
1 day ago Be among the first 25 applicants
Join to apply for the
Supply Chain Quality Senior Manager
role at
NeoImmuneTech
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, record‑keeping, 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, record‑keeping, 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.
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Quality Assurance
#J-18808-Ljbffr