Quality Associate II

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:

• Responsible to ensure compliance with Regulatory, Corporate and Local Quality requirements and for providing Quality oversight of Vantive US and Canada warehousing and distribution operations, including internal warehouse site QA activities, internal renal fleet drivers, external warehousing partners (i.e., 3PL providers, wholesalers, freight forwarders and consolidation/ deconsolidation centers), and external transportation providers.

• Oversight of distribution/warehouse-related external suppliers.

• Act as a key partner with US and Canada Vantive Operations (including Supply Chain, Logistics and Fulfillment) to manage Quality requirements and oversight of all 3PL activities.

• Responsible for compliance with FDA and Health Canada requirements, ISO standards and Vantive QMSby applying rigorous quality standards, including Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP).

What you'll be doing:

• Responsible for the implementation of 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) and internal/supplier/3PL QA management (warehouses, internal private fleet, transportation carriers, suppliers impacting fulfillment).

• Participate in discussions and on projects and cross-functional teams as required.

• Support distribution and warehousing-associated external suppliers which includes audit support, supplier corrective action requests, quality/distribution agreements, new supplier requests, supplier notifications of change and change controls.

• Work closely with UCAN planning and fulfillment organizations to meet business goals and objectives.

• Facilitate and assist in GMP, ISO, US state distribution/pharmacy licensing and other internal/external audits and investigations pertaining to Vantive and/or 3PL facilities, where applicable.

What you'll bring:

• Able to manage multiple projects and/or responsibilities simultaneously

• Support in meeting and exceeding quality key performance indicators (KPIs)

• Solid understanding of FDA Regulations, Health Canada requirements and Application of Good Distribution Practices·

• Must be proficient with Microsoft Office and other data collection/analysis programs (e.g. Minitab)

• Excellent interpersonal/communication/presentation/negotiation skills

• Must have basic English written and oral communication skills adequate to connect with other team members

• Initiative to be a subject matter expert in select processes and areas

• Supports ethical behaviors and decision-making

Education and/or

Experience:

• Bachelor’s Degree required (preferably in science, engineering or equivalent field)

• Minimum of 3 years of experience in Quality, or related field in the medical products/pharmaceutical industry

• Experience preferred for the following: distribution and warehousing in US and Canada, Quality Management Systems, FDA and Health Canada regulations, supplier quality

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