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: Quality System Manager (Pharmacist)
Reporting Manager: Head of Quality (Pharmacist)
Dotted Line: Plant Manager and Senior Quality Director (Expat)
Location: Nikom Amata City, Rayong
Normal Working Hour: Mon-Fri 8-5
Job Scope: The Quality system Manager serves as the process owner for Quality system/Compliance implementation for Amata Manufacturing facility and leads a team of Quality professionals. The position develops strategies and Annual objectives for the Quality system process which aligns with Vantive Quality strategy. This role drives successful execution to achieve plant Key performance targets and partner with Manufacturing team to develop and maintain compliant and efficient Quality system. The Quality system manager coaches, develops and mentors Quality system professionals.
Job Details:
Responsible for all related Quality System for locally Manufactured products in Thailand.
Responsible for providing leadership and guidance in establishing quality standards and specifications appropriate to Vantive’s Amata 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 plant.
Ensure adequate review and execution of qualification/validation protocols to facilitate robust manufacturing and quality standards.
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 (GQP) and Certificates of Compliance (CoC) program.
Ensure all new suppliers are properly reviewed, and New Supplier Approval Processes (Quality Agreement, Questionnaire, Facility Audit, GMP Certification are completed) are properly followed.
Responsible for quality (GMP), ISO13485 and regulatory performance in the department to ensure quality program is met.
Qualifications:
Bachelor's Degree in Pharmacy and a valid Pharmacist license.
Background in Quality Management for medical devices, pharmaceutical manufacturing, or commercial business.
Minimum 8 years of experience in Quality Assurance, Quality Control, Regulatory Affairs, or related fields.
Demonstrated interpersonal and leadership skills with ability to interface well with other departments and lead effectively and efficiently in a team environment.
Excellent in English communication skills in both, written and verbal.
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.
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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