Supply Chain Quality Manager
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Job Location:
Rockville, MD - USA
Monthly Salary:
$ 80000 - 100000
Posted on:
15 hours ago
Vacancies:
1 Vacancy
Job Summary
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 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 Designated Representative (DR) 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
- 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 companys Designated Representative under Maryland Board of Pharmacy requirements including completion of any required renewals
Qualifications
- Bachelors 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
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
Required Experience:
Manager
Key Skills
- Inventory Control
- Procurement
- SAP
- Supply Chain Experience
- SAP Supply Chain Management
- Production Planning
- Supplier Management
- ERP Systems
- Materials Management
- Logistics
- Manufacturing
- MRP
