Assoc Mgr, QE

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.

Essential Duties and Responsibilities

• Responsible for reviewing and approving D&D documents (e.g DHF and risk Management documents) and project documents from R&D team to ensure compliance with Quality requirements as defined in procedures, standards and guidelines.
• Assisting in relevant Quality System to ensure compliance with the requirements of the customers, of the authorities and of the Corporation (e;g audits )
• Provide expertise on the maintenance of Risk management and DHF deliverables to multifunctional teams within the pharmaceutical development group.
• Review and approve D&D documents including protocol and reports for quality and scientific content. Obtain agreement with the author of the documents in case of missing requirements. Requesting additional concurring personnel if necessary
• Ensure that any unusual or unexpected observations that relate to project are investigated to determine root cause, and are appropriately resolved including ensuring that the appropriate CAPA documentation is initiated when appropriate
• Manage any changes arisen from D&D stages

• Provide Guidance on maintenance product Design History Files and Risk Management Files according to relevant Quality System and other regulatory requirements for therapeutics and medical devices

• Participate in management and ensure follow-up of inspections including external inspections

• Other tasks assigned by supervisor

Qualifications

• Computer skill: Microsoft office application; Knowledge required: Word, Excel, Outlook, Minitab, SharePoint; Knowledge of statistical tools and techniques
• Technical skills: Compliance knowledge in the areas of pharmaceutical product development, change control, CAPA, and risk management; Understanding of container requirements for pharmaceutical product registration; Project management experience; familiarity with a pharmaceutical product development process; Individual must be extremely well organized, pay meticulous attention to details, and be able to articulate customer needs and incorporate into work; Ability to work with minimal supervision and to make decisions even if provided with limited information; Fluent oral and written English
• Language skills: Fluent oral and written English
• Scientific University degree (Engineering, chemistry, biochemistry...)
• Knowledge of FDA (21 CFR Part 210 & 211), ICH, and EMEA regulations (EU GMP Part I & II) and ISO 13485 and 14971
• Knowledge of SFDA regulations (GMP), GBT16886, YY T 0316-2008
• More than 5 years’ experience in the pharmaceutical/medical device environment
• Experience in leading project teams and Quality Initiatives (processes, systems, improvements) in an international environment

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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