CQA&RA specialist

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.

Summary:Under supervision responsible for the local implementation of regulatory strategies, obtain and maintain marketing authorizations for product(s).

Responsible for the maintenance of Quality Management System and related documentation, ensuring the quality compliance of commercialization, distribution, and local supplier quality management.

Essential Duties and Responsibilities:

RA Related

• Maintain regulatory files in a format consistent with requirements
• Maintain awareness of regulatory requirements; identify relevant requirements
• Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
• Maintain and update existing regulatory authorizations
• Support regulatory activities relating to specific portfolio of products/projects
• Prepare, review, and approve labeling and review AdProm materials for compliance with local regulations
• Prepare SOPs to reflect specific local requirements.
• Act as back-up of local regulatory lead when needed.

QA Related

• Compliance to Quality Management System:
- Local Documentation Coordinator (coordinate implementation at local level of corporate documentation, author and publish SOPs, SOP periodic review)
- Support Internal audit program planning and execution
- NCR/CAPA initiator, owner, investigator or task assignee as needed
- Learning professional (support training planning and carry out reporting)
- Support preparation and execution of Quality/Management Reviews

• Support Distribution operations
- Carry out transactions in the Enterprise Resource Planning (ERP) JDE to ensure adequate inventory control, traceability, tracking and release of goods
- Incoming, First of Code, Quarantine, Hold, Returned, Special importation and Unlicensed good controls

- Quality oversight of warehouse, distribution and 3PL operations
- Supplier deviation management (SCAR)

• Implementation of Field Action.

• Liaison with country functions (Supply Chain, TS, Business, Pharmacovigilance) and Third Party Logistic provider in day-by-bay activities or specific projects.

Qualifications:
• Knowledge of regulations, Good Manufacturing Practices, Distribution Practices and ISO standards
• Scientific knowledge
• Project management skills
• Manage multiple deadlines
• Ability to multitask and prioritize
• Interpersonal and communication skills
• Negotiation skills
• Technical system skills (e.g., word processing, spreadsheets, databases, online research)
• Ability to identify compliance risks and escalate when necessary

Education and/or Experience:

Bachelor’s degree or country equivalent in a scientific discipline
Minimum of 2/4 years regulatory, quality, or equivalent experience within a pharmaceutical and/or medical device company, CRO, CMO or similar organization

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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