Director, R&D Logistics and Distribution Operations

The Director R&D Logistics and Distribution Operations leads all end-to-end warehousing shipping and receiving activities for GMP and non-GMP materials at a Pharmaceutical R&D facility which includes incoming/outgoing material logistics of a North American BioCentre and global import/export operations. This role ensures compliant and efficient timebound movement of materialsincluding temperature-controlled shipments raw material deliveries and disposalswhile strictly adhering to GMP regulations SOPs and corporate standards. The Director manages internal and outsourced staff (18 personnel from third-party service providers) supporting 6000 site-based colleagues. Responsibilities extend to overseeing pest control program management ensuring all documentation is audit and inspection ready and compliant and driving continuous improvement and innovation in logistics and warehousing operations. The role is focused on building a best-in-class program by leveraging partners optimizing processes deploying advanced technologies and delivering operational excellence and superior customer service.

Key Responsibilities

GMP/Non-GMP Shipping & Receiving

• Oversight:Manage all inbound and outbound shipments of GMP and non-GMP materials including inter-site and international shipping ensuring adherence to regulatory protocols and documentation including import and export activities.
• Compliance:Ensure GMP shipments meet temperature requirements using validated cold-chain packaging and monitoring from receipt to preparation and transit. Maintain compliance with all regulations licensing permitting company SOPs and GDP (Good Distribution Practices).
• Timeliness:Guarantee timely delivery of critical raw materials for manufacturing and R&D.
• Collaboration:Coordinate closely with internal customers vendors and carriers for compliant delivery.
• Inventory Logistics & Warehousing:Oversee the logistics management for the R&D Facility and BioCentre and storage of capital equipment and FF&E both onsite and offsite.

Operational Management

• Process Control:Develop and enforce SOPs for all shipping receiving disposal and pest prevention activities.
• Continuous Improvement:Lead initiatives to improve cycle time compliance and service levels.
• Inspection Readiness:Ensure all areas are compliant with AstraZeneca safety protocols and global trade guidelines.
• Records Management:Maintain systems to track all shipments deliveries and material disposition.
• Audit Representation:Serve as the point of contact during internal audits and external inspections.

Licensing Permitting & Certifications

• Training & Certifications: Ensure trainings and certifications by support role for DOT IATA OSHA and HazMat requirements are in place to deliver materials management and logistics for all AZ and outsourced service provider staff.

• Permitting & Licensing: Ensure appropriate licenses and permits are in place and renewed in support of GMP/non-GMP and import/export regulations and compliance in categories to include but not limited to where appropriate:
  • Standard Biologics potent APIs/PAPIs
  • Infectious Substances diagnostic/clinical specimens organisms/vectors
  • Agents & Toxins
  • Controlled substances
  • Investigational products (IND/unapproved drugs) going to ex-U.S. clinical sites
  • Radiolabeled biologics/compounds

Partner with appropriate AZ stakeholders including Safety Health & Environment to ensure regulatory compliance.

Pest Control Program

• Program Management:Oversee pest control to meet GMP and corporate requirements.
• Quality Assurance:Ensure prompt identification and completion of corrective actions and documentation for regulatory audits.

• Records Management: Maintain all pest control documentation for regulatory inspections and audits.

• Training Licenses & Certifications: Ensure all training licenses and certifications are in place for physical locations and vendor personnel delivering pest control services.

Leadership & Compliance

• Team Leadership:Direct develop and train the shipping and receiving team.
• Stakeholder Collaboration:Strategize with Quality Facilities Safety Health & Environment and other partners to align operations with standards.
• Regulatory Engagement:Act as primary contact for agencies during inspections related to import/export and related warehousing operations.
• Vendor Management:Oversee third-party partner relationships for service quality and standards compliance to meet aligned goals and objectives.

Compliance Digital Technology & AI

• AI/Digital Fluency:Utilize AI-enabled platforms (e.g. predictive logistics smart tracking) to enhance operations decision making and compliance.
• Data Analytics:Ensure operational datasets are accurate structured and compliant for AI/ML applications and apply analytics for workflow and demand optimization.
• Innovation:Evaluate and integrate emerging technologies into GMP/non-GMP operations.
• Learning Agility: Adapts dapts to evolving technologies regulations and business priorities; thrives in dynamic fast-paced R&D environments.
• Change Leadership:Champion adoption of digital tools coaching teams for continuous improvement.
• Long-Term Strategy:Balance immediate operational excellence with future strategic direction to support scientific innovation.