The Clinical Supply Chain and Supply Chain Compliance (Manager/Senior Manager) will manage, design, and implement clinical and CMC supply strategies to ensure an appropriate continuous supply of material. The successful candidate will work closely with Clinical Operations, Quality, Regulatory, CMC and third-party CDMOs. Under the general direction of the Senior Director, CMC Project Management, this position will provide input and oversight to ensure all tactical operations meet or exceed cGMP regulations, ensuring high level of quality of our clinical supply chain processes.


Specific Responsibilities:

  • Develop, update, and adapt clinical supplies distribution plans based on program and study timelines, trial design, clinical program changes, recruitment, geography, and manufacturing schedules. 
  • Work with Clinical Operations to understand clinical demand requirements and ensure alignment with study teams to supply plans and timelines. 
  • Perform drug accountability with depots/clinical sites and sponsor inventories. 
  • Partner with key stakeholders including Quality Assurance and Regulatory Affairs to ensure supplies are labelled and released for global clinical trials. 
  • Coordinate primary and secondary packaging, labeling, testing, distribution, and return drug management activities with CMOs. 
  • Ensure label text and proofs are in accordance with applicable rules, regulations, product specifications, and clinical study protocol(s). 
  • Contribute to the module development within the Interactive Response Technology (IRT) system for drug supply management. 
  • Manage external consultants and third-party vendors, including collaborating with Quality Assurance on vendor selection and quality and supplier agreement development, to ensure timely and quality delivery of Clinical Trial Material (CTM) that meets study protocol, regulatory, and budgetary requirements. 
  • Interface with Quality Assurance, Manufacturing, and Regulatory Affairs to ensure trial supplies are appropriately supported including shelf life, quantities, country approvals, and specification. 
  • Develop and manage the forecasting and ordering of investigational product, commercial and comparator material in global trials and share best practices with global/local sourcing teams as appropriate. 
  • Identify gaps and make appropriate mitigation recommendations to ensure global compliance. 
  • Develop and manage SOPs, work instructions, processes, systems, and forms governing supply chain management in alignment with industry standards and regulatory requirements. 
  • Help identify, engage, and manage relationships with raw material vendors and external manufacturing/testing partners. 
  • Responsible for all logistics regarding procurement, release, testing, GMP storage, and shipping of raw materials, Drug Substance, and Drug Product. 
  • Manage GMP inventory throughout the supply chain, develop inventory reports, manage upcoming expiry, and ensure drug accountability. 
  • Responsible for managing GMP supply chain compliance, which will include ownership of associated GMP deviation and change control records related to supply and supply chain activities. 
  • Responsible for managing compliance with customs and trade requirements for Pre-Clinical and Clinical Trial Material global shipments. 
  • Coordinate courier shipments and deliveries. Manage the courier relationship. Review temperature logs for CTM distribution and storage and investigates temperature deviations according to SOP 
  • Onboard and manage relationships with contract organizations, including establishing agreements, quotes, purchase orders and invoicing. Assist Finance with inventory reconciliation and financial close. 
  • Obtain and review quotes, and approve purchase requisitions and invoices. Participate in the departmental budgeting process - forecast labeling and distribution expenses, CMC budget reconciliation and estimate headcount requirements.


Qualifications:

  • Bachelor’s degree in science-related discipline or equivalent.
  • 7+ years’ experience working in the Life Sciences industry.
  • 5+ years’ experience in cGMP materials management, with clinical supply chain experience in the biopharmaceutical industry supporting global trials being highly desirable. 
  • Thorough understanding of cGMP, GCP, and ICH standards governing IMP labeling, packaging, and global distribution (Good Distribution Practices) 
  • Strong clinical supplies management experience/knowledge in forecasting, demand/supply planning, IRT systems, inventory management, clinical labeling, distribution including cold chain, import/export, reverse logistics, CMC and GxP regulations. 
  • Fluent with all global shipping-related statutory and regulatory requirements. 
  • Knowledge of legal export/import requirements and shipping document preparation. Experience with arranging international and domestic transportation. Understand licensing, insurance and importer of record requirements. Basic understanding of tariffs / VAT in North America, Europe and Asia. 
  • Knowledge about GMP shipments, chain of custody, customs regulations is must. 
  • Experience authoring and using GxP documents such as SOP’s and work instructions. 
  • Experience in vendor oversight and managing external partnerships and relations. 
  • Experience in owning change controls, deviation investigations, CAPA implementation. 
  • Strong computer, database, and organizational skills required 
  • Ability to interpret and troubleshoot data, with excellent problem-solving skills. 
  • Highly organized and collaborate on execution of multiple parallel initiatives. 
  • Excellent communication, customer service and relationship skills are an absolute must.
This position has been filled.