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

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

• Experience in Healthcare/Pharmaceutical Quality Assurance and in warehousing and distribution of pharmaceutical/medical device products (including drugs, medical devices, biologics, SAP)

• Six Sigma Certification

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 $112,000 to $130,000 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.

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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 Illegal

Reasonable 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

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