Manager/Sr. Manager QA Supply Chain

Job Title: Manager / Senior Manager, QA Supply Chain

Location: Hybrid – Waltham, MA. Candidates will be required to be in-office 3 days/week.

 

Role Overview:

The Manager / Senior Manager, QA Supply Chain is responsible for providing quality oversight of clinical supply chain activities supporting Phase 2 and Phase 3 programs, including packaging, labeling, distribution, and cold chain management. This role ensures inspection readiness and compliance across all clinical supply operations.  This role ensures that all supply chain operations are conducted in compliance with cGMP, GCP, and GDP requirements, with a focus on IRT-driven clinical supply management, temperature control, and investigational product traceability. The individual will partner cross-functionally with Clinical Operations, CMC, Regulatory, and external vendors to ensure uninterrupted clinical supply and inspection readiness.

 

Key Responsibilities:

 Clinical Supply Chain Quality Oversight

• Provide QA oversight of clinical supply chain activities, including packaging, labeling, storage, and distribution of investigational products.
• Ensure compliance with GMP, GDP, and GCP requirements across internal teams and external vendors.
• Support phase-appropriate quality systems and procedures as programs advance from Phase 2 to Phase 3.

IRT (Interactive Response Technology) & Clinical Supply Management

• Provide QA support and oversight for IRT systems, including review and approval of system specifications, user acceptance testing (UAT), and change controls.
• Ensure appropriate controls are in place for randomization, kit assignment, and drug accountability.
• Partner with Clinical Operations and Supply Chain to ensure accurate and compliant IRT configuration and use.
• Collaborate with cross-functional clinical teams to review and update study specific pharmacy manuals.

Labeling & Packaging Operations

• Review and approve clinical labeling content, including country-specific requirements and regulatory compliance.
• Provide QA oversight of packaging and labeling operations at CMOs and depots.
• Ensure label reconciliation, issuance, and destruction processes are compliant and traceable.

Temperature Excursions & Cold Chain Management

• Oversee management of temperature excursions, including impact assessments, investigations, and disposition decisions.
• Ensure appropriate controls for cold chain logistics, including shipping qualification, lane validation, and temperature monitoring.
• Review excursion data and ensure alignment with stability data and product quality requirements.

Distribution & Logistics Oversight

• Provide QA oversight of global distribution activities, including depot operations and comparator sourcing.
• Ensure chain of custody and chain of identity are maintained for all investigational products.
• Support qualification and oversight of depots, logistics providers, and distribution partners.

Deviations, Product Complaints & CAPA

• Lead or support investigations related to deviations, temperature excursions, shipment issues, product complaints, and labeling errors.
• Ensure timely and thorough root cause analysis and CAPA implementation.
• Track and trend supply chain quality events to identify systemic improvements.

Regulatory & Inspection-Readiness

• Support QA Supply Chain activities for regulatory submissions and inspections.
• Ensure documentation and systems are inspection-ready for clinical and late-stage de