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: Senior Quality Manager (Healthcare Manufacturing)

Reporting Manager: Senior Quality Director, APAC

Dotted Line: Plant Manager, Thailand

Location: Vantive Manufacturing Plant, Nikom Amata City, Rayong

Normal Working Hour: Mon-Fri 8-5

Job Scope:

Develop and deploys the quality system for the Thailand Renal Plant (Sterile). Assures systems and procedures for regulatory compliance are established and deployed. Management representative for the Amata plant quality system and periodically reviews the suitability and effectiveness of the quality system with executive management.

Key Responsibilities

Provide leadership role to lead Quality Management function in Thailand.

• Responsible for all related Quality Assurance and Quality control responsibility for locally Manufactured products in Thailand.

• Responsible for providing leadership and guidance in establishing quality standards and specifications appropriate to Vantive's Renal plant in Thailand.

• Responsible for working closely with Vantive Thailand business unit and Supply Chain to meet Vantive Renal business goals.

• Ensure and responsible for compliance to Vantive and local Regulatory requirements for manufacturing in Thailand.

• Ensure that the Thai Renal manufacturing site meets Vantive and Thai GMP requirements.

• Recruit a quality organization to ensure execution of Vantive Quality system in the Thai renal plan.

• Ensure adequate review and execution of qualification/validation protocols to facilitate a robust manufacturing and quality standard.

• Establish a robust quality system with adequate procedures to ensure compliance always.

• Analyze and advise on required process changes and implementation, and provide training, tools and techniques to enable others to achieve quality.

• Ensure compliance with Vantive's Global Quality Procedures (VGQS) and Certificates of Compliance (CoC) program.

• Responsibilities to maintain a system or have some shared, or jointly exercised, responsibility relating to quality. These may include, subject to any national regulations.

Qualifications

Bachelor's degree in Pharmacy or a related Science or Engineering field.

• Background in Quality Management within a Medical Device or Pharmaceutical Manufacturing environment.

• More than 8 years in Quality Assurance, Quality Control, Regulatory Affairs and related.

• Well as knowledgeable in PIC/S Regulation and working with Ministry of Health.

• Excellent in English communication skills in both, written and verbal. (Reporting to Expat Sr. Director)

• Strategic Leadership

• Quality & Compliance Mindset

• People Management & Development

• Stakeholder Management

• Problem Solving & Decision Making

• Influencing & Communication Skills

• Business Partnership

Benefit & Welfare:

• Base Salary

• Fixed Bonus

• Pharmacist License Allowance

• Housing Allowance

• Transportation Allowance or Shuttle Van Provided

• Variable Bonus

• Group Life & Health Insurance

• Working Mon-Fri 8-5

• Etc.