Director - Materials Management

Reference Number: i2iQBy
Location: San Diego, California, US

The purpose of this position will be to maintain / improve all policies, procedures, and infrastructure in support of SCC supply chain organization as well as provide overall management and leadership associated with commercial drug product supply to include EXPAREL and future drug candidates as directed by Executive Leadership Team (ELT). The incumbent will ensure the adequate stock and supply of all products for the US commercial market as well as in support of all future clinical and developmental products.  The incumbent will be the Subject Matter Expert (SME) for all Materials Management programs and activities for the company to include but not limited to Supply Chain Security/Product Serialization, as well as supply risk assessment and migration activities to meet current and future industry standards.  The incumbent will also support the development of a Global Supply Chain infrastructure as requested by the VP, Global Supply Chain.

 

 

  • Leads, manages, and develops assigned functional teams to high levels of effectiveness, responsiveness and continuous improvement in accordance with organization goals and objectives.
  • Provides oversight and support to the development and implementation of new solutions or strategic / tactical plans that improve systems capabilities to enable more effective and efficient processes.
  • Develop standard operating procedures and documentation for functional areas to assure compliance to all Regulatory agency requirements. Provide training and development to staff.
  • Develop and implement business plans to mitigate risk to include back up sources of supply for materials and manufacturing operations.
  • Oversee the preparation of long and short term Manufacturing Plans from external and internal demand forecasts.  Develop GMP material procurement plans to ensure delivery times are consistent to support manufacturing plan.  Analyzes and manages inventory to expected levels of availability, accuracy, usage and age.
  • Develop and maintain expense budget and material procurement plan.
  • Oversee the execution of supply of finished products for the US Market to meet customer and company goals.
  • Provide leadership for new product development relationships in the areas of product supply and logistics.
  • Develop and manage key performance indicators for department to assure continuous improvement and department objectives are met.
  • Assists with the development of purchasing policies and procedures for raw materials, services, and supplies with adherence to regulatory standards.
  • Key member of the NCMR team to address non-conforming materials.
  • Coordinate procurement requirements with the commercialization team to assure raw materials and supplies are available to achieve manufacturing timelines and operational activities.
  • Identifies and executes cost improvement strategies encompassing supply chain operations. 
  • Work directly with the Contract Manufacturing Organization and Manufacturing Operations to ensure FG inventory targets are achieved.
  • Responsible for overseeing product security and cold chain integrity in the supply chain, and leads the efforts for packaging design development. Expert on import & export regulations. Expert in Global Supply Chain Pharmaceutical regulations
  • Responsible for inbound and outbound transportation
  • Responsible for internal warehousing and supply operations
  • Responsible for weigh and dispense activities in support of all commercial, clinical and developmental products.

 

The qualified candidate will possess the following:

  

  • 18 years of relevant experience with 12+ years in supply/manufacturing operations management roles in a regulated industry (FDA/EMA).
  • BA/BS degree in business management or equivalent.  MBA Preferred. 
  • Strong leader with proven record of consistent high performance delivering results, leading projects and implementing solutions with systems and processes, developing subordinates and who is capable of managing complex relationships in a fast-paced, dynamic environment.
  • Experienced supply chain management professional (Certified Production and Inventory Manager, CPIM) preferred.
  • Experienced in all aspects of materials management in a biomedical/pharmaceutical manufacturing capacity.  Must be familiar with cGXP requirements, FDA, EMEA, Health Canada regulations.
  • Experienced with the use and implementation of Enterprise Resource Planning systems (ERP) systems.
  • Experience in warehousing and distribution practices with an emphasis in cold chain management.
  • Ability to work both independently and in a team environment.
  • Must be able to lead and execute complex projects.
  • Excellent planning, organizing and executing skills. 
  • Must be results driven and capable of bringing increased value to the company.
  • Excellent oral, written and interpersonal communication skills with good presentation skills.
  • Ability to work in an entrepreneurial environment and function with a “roll up the sleeves” approach.
  • Leadership experience with supplier development projects.
  • Leadership experience in a rapidly changing, dynamic environment; expert in change management.
Standard Management (Manager/Supervisor of Staff)
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