Associate Director, Clinical Supply

About the role

The Senior Supply Chain Manager/Associate Director (AD) is responsible for leading and supporting pharmaceutical supply chain operations with a strong focus on packaging, transportation, cold chain, and shipping validation activities. This role ensures the compliant storage, packaging, distribution, and shipment of clinical and commercial pharmaceutical products while maintaining adherence to cGMP, GDP, regulatory requirements, and company quality standards.

Responsibilities

• Manage end-to-end pharmaceutical supply chain activities for clinical and commercial products, focused on logistic and packaging operations.
• Cook up packaging, labeling, warehousing, inventory management, and distribution activities.
• Coordinate domestic and international shipments, including import/export documentation and customs requirements.
• Partner with CMOs, depots, 3PLs, CROs and transportation providers to ensure supply continuity and service performance.
• Develop and maintain supply chain metrics, dashboards, forecasts, and inventory plans.
• Lead shipping validation studies for ambient, refrigerated, frozen, and ultra-low temperature products.
• Develop, review, and approve validation protocols, reports, risk assessments, and qualification documentation.
• Design and execute packaging qualification and transportation validation programs.
• Support lane qualification, route validation, temperature mapping, and seasonal shipping studies.
• Audit and qualify shipping systems, insulated containers, refrigerants, temperature monitoring devices, and packaging configurations.
• Evaluate shipping excursion data and implement corrective actions when needed.
• Maintain shipping validation programs in a state of continuous compliance through periodic review and requalification activities.
• Ensure compliance with GMP, GDP, FDA, EMA, ICH, USP, and applicable global distribution regulations.
• Support deviation investigations, CAPA implementation, change control, and risk management activities.
• Participate in internal audits, supplier audits, and regulatory inspections.
• Establish and maintain quality agreements with logistics providers and packaging vendors.
• Ensure all supply chain processes remain inspection-ready and properly documented.
• Manage relationships with third-party logistics providers, depots, freight forwarders, packaging vendors, and CMOs.
• Lead contractor qualification, onboarding, performance monitoring, and quality oversight activities.
• Review service metrics, implement improvements, and resolve operational issues.
• Drive continuous improvement initiatives related to transportation performance, cost optimization, packaging efficiency, and product protection.

Qualifications

• Bachelor's degree in Supply Chain Management, Logistics, Engineering, Life Sciences, Pharmaceutical Sciences, or related discipline.
• 5+ years (Senior Manager) or 8+ years (AD) of pharmaceutical, biotechnology, or regulated healthcare supply chain experience.
• Demonstrated experience with packaging qualification and shipping validation programs.
• Working knowledge of GMP, GDP, temperature-controlled logistics, and pharmaceutical distribution requirements.
• Experience developing and executing validation protocols, risk assessments, and qualification reports.
• Strong understanding of cold chain packaging systems, temperature monitoring technologies, and distribution risk management.
• Experience managing third-party logistics providers and contract service organizations.
• Excellent project management, communication, and organizational skills.
• Proficiency with Microsoft Office and supply chain management systems.

Preferred Qualifications

• Experience supporting clinical trial material supply and/or commercial product distribution.
• Hands-on experience with: Shipping lane qualification, Seasonal shipping validation, Temperature mapping studies, Warehouse qualification, Cold chain packaging qualification, Data logger qualification and monitoring systems.
• Knowledge of FDA, EMA, WHO, ICH, USP, and GDP guidance.
• PMP certification and/or APICS certification preferred.
• Experience with biologics, cell and gene therapy, vaccines, or other temperature-sensitive pharmaceutical products.

Core Competencies

• Pharmaceutical Supply Chain Management
• Package Qualification
• Shipping Validation
• Cold Chain Logistics
• GDP/GMP Compliance
• Risk Assessment and Mitigation
• Deviation Investigation and CAPA
• Vendor Management
• Project Leadership
• Cross-Functional Collaboration
• Continuous Improvement
• Regulatory Inspection Readiness

Travel Requirements

Up to 20–30% travel for site visits, audits, vendor oversight, validation activities, and business meetings.

Must be authorized to work in the US

No sponsorships available. We are not accepting resumes from agencies at this time.