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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 development programs.
• Support responses to health authority inquiries related to clinical supply chain operations.

Qualifications:

Required

• Bachelor's degree in Life Sciences, Supply Chain, or related discipline.
• 5+ years (Manager) or 8+ years (Senior Manager) of experience in Quality Assurance within GMP/GDP environments.
• Experience supporting clinical supply chain operations in Phase 2 and/or Phase 3 trials.
• Working knowledge of GMP, GDP, and GCP regulations applicable to investigational products.
• Experience with IRT systems and clinical supply management processes.
• Hands-on experience with clinical labeling, packaging, and distribution oversight.
• Experience managing temperature excursions and cold chain logistics.
• Familiarity with deviation management, investigations, and CAPA systems.
• Strong organizational and problem-solving skills with attention to detail.
• Ability to work cross-functionally and manage multiple priorities in a fast-paced environment.

Preferred

• Experience supporting global clinical trials and multi-region supply chains.
• Experience with comparator sourcing and depot management.
• Familiarity with electronic quality systems (eQMS) and IRT platforms.
• Experience participating in regulatory inspections.
• Background in biologics or combination products.

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates who will work in Waltham, MA for Manager level is $146,000 - $161,000 and for Sr. Manager is $161,000 - $187,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

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

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.