Regional Fluid Quality Management Lead

This role oversees the management of fluid quality within the regional APAC area. The Senior Manager Regional Fluid Quality will be responsible for implementing and maintaining a monitoring, reporting, and training system related to dialysis fluid quality and water treatment system parameters.

Key responsibilities include training qualified personnel for routine monitoring and water quality-related activities, approving accreditation of proper laboratories, supervising water treatment systems, and performing risk assessments for items such as concurrent validation and deviations from requirements.

Additionally, this role involves immediate correction and corrective actions/risk reduction measures in case of critical deviations, with assistance from regional and local teams.

The ideal candidate should have academic degrees with additional specialized qualifications or subject-related education, preferably in technical, engineering, or healthcare services.

Project Management experience on Water Treatment Systems and knowledge of international and regional regulations on Water Treatment Systems are also required.

Furthermore, corporate FQR qualification training on international/local legal regulations, corporate water directives, microbial management, and basic WTS engineering would be an asset.

This position requires at least 2-4 years of professional experience in equivalent or similar functions, ideally in a technical, engineering, healthcare, or healthcare-related environment.

• Implementation of a monitoring, reporting and training system related to dialysis fluid quality and water treatment system parameters as input for data evaluation (e.g., quarterly reporting of relevant parameters by the clinic to country headquarters).
• Training of qualified personnel for routine monitoring and water quality related activities.
• Approval of accreditation of proper laboratory.
• Supervise water treatment systems (WTS) and dialysis fluid quality monitoring processes in dialysis clinics, including periodic evaluation of routine monitoring results (e.g., data correctness, compliance with fluid quality requirements).
• Root-cause analysis and risk evaluation in case of critical deviations in dialysis fluid or WTS parameters, with assistance from regional and local Technical Operations and Clinic Quality Management teams.
• Performance of risk assessments for items such as concurrent validation and deviations from requirements.
• Execution of immediate correction and corrective actions / risk reduction measures in case of critical deviations, with assistance from regional and local teams.
• Immediate reporting to CDI management in case of critical deviations of dialysis fluid quality or WTS parameters.
• Support of responsible functions at clinic and country level in implementation of related standards and processes.
• Collaborate with local Technical Operations Team, Project Planners and external vendors (if required) to select water treatment and concentrate delivery systems, validation, routine monitoring, disinfection and sampling plans to ensure proper operations of the WTS.
• Plan validation and re-validation processes with support from local teams, train qualified personnel in implementation of validation/re-validation.
• Document all relevant reports (e.g., re-/validation, risk assessments, disinfection and sampling protocols) in an organized and well-structured manner.
• Support local country organizations and management during internal and external audits by providing audit-relevant documents and participation during audits.
• Supervise and support the APAC Country FQR with appropriate guidance and oversight.

• Academic degree with additional specialized qualification or subject-related education, preferably in technical, engineering or healthcare services.
• Project Management experience on Water Treatment Systems.
• Knowledge of international and regional regulations on Water Treatment Systems.
• Preferably, corporate FQR qualification training on international/local legal regulations, corporate water directives, microbial management and basic WTS engineering.
• At least 2–4 years of professional experience in equivalent or similar functions, ideally in a technical, engineering, healthcare or healthcare-related environment.
• Highly professional attitude with a result-, quality-, patient- and customer-oriented working style.
• Strong interpersonal skills, motivation, and ability to connect teams; ability to work under pressure with a structured, pragmatic approach.
• Ability to set priorities, manage high-volume workload, think strategically and make qualitative decisions under changing conditions.
• Strong analytical and problem-solving skills; highly organized with a focus on efficient processes.
• Change, negotiation and conflict management skills; basic presentation, facilitation and training capabilities; high resilience and flexibility.
• Technical knowledge of water treatment system components and related medical devices; understanding of potential impacts of contaminated water/dialysis fluids on patients; chemical and microbiological knowledge related to water and dialysis fluids.
• Knowledge of applicable legal and IMS requirements; ability to evaluate economic impact of decisions.
• IT skills and proficiency with standard software (MS Office, intranet); basic understanding of e-health, data security, and related topics.
• Languages: fluent in country language and English (speaking, reading, writing); other languages are an asset.

• Willingness to travel within the region and across time zones as required.

Note: This description focuses on the responsibilities and qualifications for the Senior Manager Regional Fluid Quality - APAC role. It excludes extraneous job-board postings and unrelated content.