QA & Ra Manager, Vietnam and Myanmar

5 days ago

Hà Nội, Vietnam Vantive Full time

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.

**Position**:QA & RA Manager, Vietnam and Myanmar

**Responsible**: Vietnam 85%/ Myanmar 15%

**Work Office**:Vantive Healthcare, Hanoi Office.

**Reporting Manager**:Associate QA & RA Director (Based in New Zealand)

**Product**:Medical Devices and Pharmaceuticals

**Job Scope**:

- Member of Vietnam Leadership team.
- Responsible for ensuring compliance to Product release/ Labelling process followed at controlled warehouse and implementation and control of product complaints management for products sold in the Vietnam / Myanmar market.
- As RA head, be responsible to anticipate and articulate current and future regulator expectations for successful outcomes, including precedence and policy shifts where appropriate. Interpret and communicate regulations and ensure compliance. Manage timely product registration
- As a Quality Management Representative for Vietman responsible to effective implementation of the regulations for Good Distribution Practice of Pharmaceutical Products (GDP). Maintain the GDP certificate to continue permit for Pharma business.

**Job Descriptions**:

- Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations.
- Represent or lead the RA function on assigned cross-functional project teams.
- Monitor applicable regulatory requirements; assure compliance with, and external standards. For example, implement the requirement of medical devices labeling which include Product label and IFU for Vietnma specific information e.g., Local license number, Local MAH, etc.
- Establish appropriate communication within RA and other functions primarily at project level.
- Review promotional material or SOP’s for compliance with local and global regulations.
- Represent Vantive interests with government and industry working groups
- Implements the quality systems procedures and manages quality compliance.
- Act as the designated responsible person for GDP in accordance with Vietnam regulatory requirements
- Responsible for Field Action (FA) such as customer notification letters, product on hold and product recall activities.
- Manage all the customer issues reported and timely reporting of received information through CMS and uses it for improvements in products and services; act with customer in mind.
- Responsible to compliance to MDR (Medical Device Reporting) regulation including the reporting requirements for foreign safety information to Thai MOH every six months.
- Responsible for local NCR and CAPA management and implementation of change control.
- Manage quality related activities for Warehousing, Distribution and Technical service center. Implementation of Quality Management of Third part warehouse and control of labeling activities.
- May perform supplier audits and manage supplier quality
- Participate in or manage quality assessments of internal operations and suppliers to analyze compliance and assess risk.
- Provide direct supervision of individuals
- Establish communication and good working relationships internally, within QARA, other functions and externally with various government authorities.

**Qualifications**:

- Bachelor of Science such as Pharmacy, Engineering, Chemical, or any related fields, etc.
- At least 7 years working experienced in Regulatory and Quality Management for International Healthcare Companies.
- At least 2 years of People Managment Experience.
- Ability to multitask and prioritize.
- Advance of regulatory knowledge and strategy.
- Knowledge of applicable regulatory laws & acts and well versed with changing scope and evolving regulations.
- Ability to independently identify compliance risks and escalate when necessary.
- Ability to collaborate with different functions to effect change, including Quality Assurance, Clinical Operations, Supply Chain and Logistics, Manufacturing, Marketing, Sales and other business development entities in the organization.
- Business Level of English P

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