NeoImmuneTech · 1 month ago
Supply Chain Quality Manager
Rockville, Maryland, United States
Full-time
Onsite
Mid, Senior Level
$80K/yr - $100K/yr
3+ years expNeoImmuneTech, Inc. is a clinical-stage T cell-focused biopharmaceutical company dedicated to expanding the horizon of immuno-oncology. The Supply Chain Quality Manager will support pharmaceutical distribution activities, ensuring compliance with regulatory standards and overseeing distribution, storage, and facility operations.
BiotechnologyHealth CareTherapeutics
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
Ensure physical presence at the facility during regular business hours, as required to serve as Designated Representative
Maintain qualification and eligibility to serve as the company’s Designated Representative under Maryland Board of Pharmacy requirements, including completion of any required renewals
Qualification
Required
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 Designated Representative eligibility requirements
Benefits
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
Company
NeoImmuneTech
NeoImmuneTech is a biotech company developing T cell-centered novel immunotherapeutics.
51-200 employees
H1B Sponsorship
NeoImmuneTech has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2022 (2)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
unknown2021-03-16IPO
2018-01-01Series Unknown
Leadership Team
Luke Oh
Chief Executive Officer
Recent News
Pharmaceutical Technology
2026-01-03
2025-12-31
Business Wire
2025-12-31
Company data provided by crunchbase