The Quality Associate II is responsible for ensuring compliance with FDA, Health Canada, and internal quality standards across warehousing, distribution, and transportation operations in the US and Canada. This role involves managing quality oversight of internal and external suppliers, conducting audits, and supporting continuous improvement in supply chain quality management. The position requires knowledge of quality management systems, regulatory compliance, and experience in medical products or pharmaceutical distribution environments.
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:
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: distribution and warehousing in US and Canada, Quality Management Systems, FDA and Health Canada regulations, supplier quality
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
Vantive is committed to supporting the need for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.
We understand compensation is an important factor as you consider the next step in your career. At Vantive, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $80,000 to $95,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
US Benefits at Vantive
This is where your well-being matters. Vantive offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical, dental and vision coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Aon Pooled Employer Plan (“Aon PEP”), Vantive’s 401(k) retirement savings plan, to help you prepare for your future. The Aon PEP is designed to help improve retirement outcomes by providing retirement resources more efficiently. The plan offers a robust set of investment options, financial education, and a suite of resources to support your retirement goals.
We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Vantive’s US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Vantive
Equal Employment Opportunity
Vantive is an equal opportunity employer. Vantive evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Know Your Rights: Workplace Discrimination is IllegalReasonable Accommodation
Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link
Recruitment Fraud Notice
Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice .Quality Assurance, FDA Compliance, Health Canada Regulations, Distribution Quality, Warehousing Quality, Good Manufacturing Practices, Supplier Quality Management, 3PL Oversight, Medical Products, Pharmaceutical Quality
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