Quality Manager, Warehouse & Distribution

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Your Role:

In this role, you will lead oversight of Quality-impacting activities for third-party logistics receiving/distribution center(s). Collaborate with third-party logistics service providers in management of quality-impacting issues, management review, site QA management (pest control, temperature monitoring, returns, validation) and Quality Management System (QMS)-related activities (such as document revisions). You will support UCAN Quality Distribution activities such as issue management (product dispositions, deviations, complaint investigations, holds), internal/supplier/3PL QA management (warehouses, internal private fleet, transportation carriers, suppliers impacting fulfillment), internal/external audits including in support of SQLM, new initiatives/projects

What you'll be doing:

• Responsible for the oversight of Quality-impacting activities for third-party logistics distribution center(s).

• Conduct Distribution QA activities to ensure compliance to FDA and Health Canada requirements. This includes activities related to issue management (product dispositions, deviations, complaint investigations, holds), site QA management (pest control, temperature monitoring, returns, validation, establishing and overseeing protocols) and internal/supplier/3PL QA management (warehouses, internal private fleet, transportation carriers, suppliers impacting fulfillment).

• Independent decision making for resolving unexpected and critical distribution and warehousing issues. On-site GEMBA walks, supplier collaboration, process improvements, and gap assessments.

• Support key projects related to distribution quality e.g. new warehouses, new carriers, new vendors, lane qualifications, temperature mapping, process improvements

• Facilitating and assisting in internal/external audits and investigations (e.g. SQLM, GMP, ISO, US state distribution/pharmacy licensing) pertaining to Vantive or 3PL facilities, where applicable.

• Build strong relationships with key suppliers and through industry associations drive company interests and alignment of best practices for distribution quality.

What you'll bring:

• Post-Secondary Degree in Science, Engineering, or equivalent combination of experience and education. 

• Minimum 5 years of experience in Quality Assurance

• Prior experience in warehouse quality

• Supervisory or management experience working in a Health Canada and/or FDA regulated environment for drugs and devices

• Knowledge of GMP, ISO standards and regulatory requirements for distribution quality activities

• Project management fundamentals

• Strong communication skills and ability to work with all levels of the organization

• Ability to build strong relationships with internal and external customers

• Strong analytical and problem-solving skills

• Time management (balancing competing priorities)

• Independent decision making for unexpected and critical issues

• Preferred Skills/Special Training/Technical Skills:

• GMP and ISO 13485 audit experience

• Experience working with third-party logistics vendors specializing in distribution (warehousing and transportation)

• Experience with transportation and warehouse validation, qualification and protocol activities

Nice to have:

• B.Sc. in Chemistry or Microbiology, or equivalent 

• Post graduate training in Regulatory Affairs and Quality Operations 

• 5 – 10 years of experience in Quality Assurance

• Supe