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Our Vision is to be the preferred talent partner in Asia to accurately identify and integrate high potential talents for our clients and accomplish career success for our candidates.

The Quality Director will oversee Overall quality delivery of the companys business including Quality Assurance and Quality Control functions at all Manufacturing locations and control of quality from outsource suppliers. The position will effectively manage the Manufacturing and Sourcing Quality departments, including staff supervision and ensuring team have the appropriate skills, education and training for their roles. 

The job encompasses 4 broad pillars manufacturing quality operations, quality management systems, people development and transformation. The Quality Director is expected to work closely with line management and Supply leadership on setting up quality organization with quality by design mindset and at same time driving operational delivery and transformational changes within organization. The role requires individuals to drive high effectiveness in current day to day operations while keeping up momentum on transformational changes to step change the organizations quality performance.



The Challenges

 

  • 1) Quality in Operations (QC/QA)
    Leadership
    Provide a strategic direction and tactical focus to the Product Quality Engineering and influence the direction of business unit QA activities.
    Leverages relationships with cross functional managers within business unit to set key goals.
    Participate in relevant ISO Technical Committees.
    Chair meetings required to drive closure of quality issues at monthly intervals.
    Chair crisis management meetings to drive escalation and solutions.
    Drive updates to CEO Level on overall quality program and its progress.
    Takes authority to make decisions in event of any non-compliant product or processes.
    Quality engineering
    Designs, develops, and implements comprehensive quality engineering programs that is designed to drive high success rates, mitigates key potential risks to drive better consumer satisfaction, exceeds manufacturing targets, meets regulatory requirements, sets up organization to prevent critical events from arising and indemnify business against external impacts.
    Analyze, identify and detect drivers of improvement of quality during new product development and existing production.
    Drive analysis methods and systems to drive quality efforts both top-down and bottom-up directions to rapidly improve pre-QA quality performance including overall QC function.
    Work with R&D and supply technical on overall specifications for in process and finished goods. Set up more effective internal controls within scope of existing registrations on existing products to minimize registration upgrades.
    Drive feed forward approach of Quality engineering on remediation of plant capability matrices on process validation and stability.
    Normalize and standardize testing methods and test equipment on par with industry trends.

    Operational aspects
    Manage and develop the QA teams at the manufacturing facilities and QA sourcing.
    Ensure all Quality Management System and product related problems are elevated to the Senior Director and the relevant Operations General Managers.
    Ensure compliance to all relevant manufacturing Standards ie ISO13485, ISO9001, MDSAP etc,
    Ensure Good Manufacturing Principles are applied.
    Ensure plants meet and have all local manufacturing licenses in place.
    Ensure compliance to all product related Standards in the markets to which products are supplied for all products (in-house manufacturing and insourcing)
    Ensure customer requirements and all regulatory requirements are met.
    Communicate any changes relating to Standards or quality best practice to Operations.

    2) Quality Management system
    Simplify and harmonize QMS to make it more practical and adoptable at all levels.
    Drive updates to QMS and SOP matrix as needed with a 3-year view.
    Set annual quality KPIs in association with relevant Operations General Managers.
    Measure and report on KPIs on monthly basis and ensure corrective and preventive actions are implemented where required.
    Drive replicable and reproducible models in areas of CAPA, change control and deviations that result in faster lead time to conclusion and improved accuracy levels.
    Conducts periodic review of the Quality Program with senior leadership.

    3) People development and Culture
    Recruit, select, and on-board top talent.
    Develop and implement initiatives to promote ownership of quality and a positive quality mindset for all personnel in the Quality, Operations and Sourcing/Supply teams.
    Provide training and ensure competency on key quality concepts for the Quality and Operations teams including but not limited to: CAPA, Change Control, Statistical techniques, applicable Standards ie ISO13485, ISO9001, MDSAP, ISO4074, ISO23409, 21 CFR etc.
    Setting up of team and changes associated to drive quality by design mindset.
    Improved talent profile in team to be developed (in-house and external hiring) on quality engineering part.

    4) Transformation
    Drive standardization of quality activities between the manufacturing sites including but not limited to QMS, raw materials, sourcing etc. wherever possible.
    Develop and implement IT system to ensure high level of data integrity and faster/agile alerts.
    Develop and deploy impactful software system for change controls and Specification management.
    Develop and deploy real time monitoring IT dashboard to support Operations director in taking faster data.
    Step change transfer process between NPD and supply operations.
    Set up gold standard for process validation for future.

What It Takes

  • Masters degree and above in science/technology or related subjects.
  • Formal qualification and hands on experience of application of statistical methods
  • Minimum 10 years experience in Quality leadership
  • Proven experience in health care and/or medical industry leading quality function for manufacturing sites.
  • Proven experience in driving operational quality aspect with hands on experience for transformation (culture, IT Deployment, hiring and training)
  • Previous experience and compatibility to work with Thai Culture is key.
  • Proven experience of working with wide
  • Thorough knowledge of FDA Quality System requirements, ISO 13485 (Quality System) requirements, ISO 9001, ISO 14971 (Risk Management) requirements, Medical Device Regulation (MDR) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards

Interested candidates, please click the Apply For This Job Button.
All information will be kept in the strictest confidentiality.Priority responses will be given to candidates who are shortlisted.
Employment Agency No: 11C5794