Manager/Sr. Manager QA Supply Chain

Key Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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

• 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.

Benefits

• A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
• Competitive salary and benefits package.
• A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
• Opportunities for professional growth and development.