Total 88 quality assurance engineer job vacancies in Quality Assurance / Control category in The Philippines

Responsibilities:

• Read blueprints and instructions to comprehend the quality expectations for the product and supplies.
• Approve or reject raw materials with respect to quality standards and record supplier performance.
• Choose output samples and check them using appropriate methods (measuring dimensions, testing functionality, comparing to specifications etc.).
• Utilise automated systems to perform complex testing procedures.
• Manage records of testing, information and various metrics such as number of defective products per day etc.
• Oversee procedures of the entire production cycle to ensure they are efficient and comply with safety standards.
• Monitor the use of equipment to ensure it is safe and well-maintained and discard any that doesn't meet requirements.
• Document and submit reports to the quality manager.

Requirements:

• Proven experience as quality inspector or relevant role.
• A sharp eye for detail and a results-driven approach.
• Responsible and trustworthy.
• Experienced with quality testing machines and systems.
• Thorough knowledge of quality control standards and testing methodologies.
• Certification of quality control is a strong advantage (ISO 9000 etc.).
• Working knowledge of MS Office.
• Minimum SPM/O level or equivalent; Further qualifications will be a plus.

Perks & Benefits

• Medical insurance

The Quality and Environment Executive is responsible to support the HSE Manager coordinate and implement activities in maintaining the Quality Management System and Environmental Management System. The incumbent is also required to be the point of reference in ensuring the plants complies with the local legislation on Environment.

Specific accountabilities and job functions will be but are not limited to:

• Responsible for the implementation and execution of ISO Management System.
• Responsible for the Internal Audit and Management Review as stipulated by the ISO system. Roles includes planning, conducting and reporting.
• Responsible for identifying, monitoring and controlling of documentation.
• Responsible for effective management of environmental issues in compliance with local laws and company policy.
• To prepare monthly department activity report.
• Liasons with external parties on matters concerning ISO Quality & Environmental Management
• To provide awareness and familiarisation training to new employees on matter relating to Quality & Environmental Management.
• Responsible for effective management of environmental aspects and impacts, ensuring compliance with Malaysian environmental legislation including the Environmental Quality Act 1974 (EQA) and its subsidiary regulations.
• In the absence of HSE Manager, to perform his/her duties on matters related to quality & environmental management system.
• To prepare and submit the Cementir Environmental report yearly.
• To liase with DOE on matters concerning scheduled waste.
• Responsible to submit reports and correspondences required by DOE.
• Play the role as Certified Environmental Professional in Scheduled Waste Management (CePSWaM) for our company.
• Taking up any other roles assigned by the HSE Manager or the management of the company whenever required

Job Requirements

• Minimum Diploma in any field.
• 1–2 years of working experience in Quality Management System (QMS) and/or Environmental Management System (EMS), preferably within a manufacturing environment.
• Registered with the Department of Environment (DOE) as a Certified Environmental Professional in Scheduled Waste Management (CePSWaM).
• ISO Lead Auditor certification (ISO 9001 / ISO 14001 / ISO 45001) is an added advantage.

Perks & Benefits

• Employee equity
• Allowance (travel stipends, transportation, etc.)
• Medical insurance
• Personal leave

職責：

• 閱讀藍圖和說明書，了解產品和材料的品質要求。
• 根據品質標準批准或拒絕原料，並記錄供應商績效。
• 選擇輸出樣本，並使用適當的方法進行檢查（測量尺寸、測試功能、與規格進行比較等）。
• 利用自動化系統執行複雜的測試程序。
• 管理測試記錄、資訊和各種指標，例如每天的缺陷產品數量等。
• 監督整個生產週期的各項流程，確保其高效運作並符合安全標準。
• 監督設備的使用情況，確保其安全且維護良好，並丟棄任何不符合要求的設備。
• 向品質經理提交文件和報告。

要求：

• 具備品質檢驗員或相關職位的工作經驗。
• 敏銳的洞察力和以結果為導向的工作方式。
• 負責任且值得信賴。
• 熟悉品質檢測設備和系統。
• 精通品質控制標準和測試方法。
• 品質控制認證是一項很大的優勢（ISO 9000 等）。
• 熟練微軟辦公軟體。
• 最低要求為SPM/O水準或同等學歷；擁有更高學歷者優先考慮。

福利待遇

• 醫療保險

品質與環境主管負責協助健康、安全與環境經理協調並執行各項活動，以維護品質管理系統和環境管理系統。此外，該職位還需作為聯絡人，確保工廠遵守當地環境法規。

具體職責和工作職能包括但不限於：

• 負責ISO管理系統的實施與執行。
• 負責依ISO體系規定進行內部審核與管理評審工作。職責包括計劃、實施和報告。
• 負責識別、監控和控製文件。
• 負責有效管理環境議題，遵守當地法律和公司政策。
• 準備部門每月活動報告。
• 與外部各方就ISO品質與環境管理相關事宜進行聯絡
• 為新員工提供有關品質和環境管理的意識和熟悉性培訓。
• 負責有效管理環境因素和影響，確保遵守馬來西亞環境法律，包括 1974 年環境品質法 (EQA) 及其附屬法規。
• 在 HSE 經理缺席的情況下，履行其在品質和環境管理系統相關事宜上的職責。
• 每年編制並提交 Cementir 環境報告。
• 就計劃處置廢棄物的相關事宜與能源部進行聯絡。
• 負責提交美國能源部要求的報告和信件。
• 擔任本公司註冊環境專業人員（CePSWaM）一職。
• 根據公司健康、安全與環境經理或管理層的指示，在需要時承擔其他任何職責。

職位要求

• 任何專業最低學歷要求為大專。
• 1-2 年品質管理系統 (QMS) 和/或環境管理系統 (EMS) 工作經驗，最好是在製造業環境中。
• 已在環境部 (DOE) 註冊為註冊環境專業人員（CePSWaM）。
• 擁有 ISO 主任審核員認證（ISO 9001 / ISO 14001 / ISO 45001）是一項額外優勢。

福利待遇

• 員工權益
• 津貼（旅費、交通費等）
• 醫療保險
• 個人休假

Responsibilities and Authorities:
1. Handling of quality complaints, ensure they are resolve satisfactorily with necessary counter measures taken to prevent recurrence
2. Analysis quality problem found by QC Inspectors and interacting with other departments on problem resolution
3. Recommend quality improvement actions
4. Perform routine site inspections & quality reporting ( Certificate ) to customer
5. Perform Lab analysis
6. Authorized in Inspection & Test Plan at production 
7. Authorized to train QC base on Inspection & Test Plan and Quality Control Work Instruction
8. Authorized to reject, on-hold the material in various production stage
9. To ensure equipment are comply to calibration process and keep track on the validity period
10. Knowledgeable in ISO 9001:2015 Quality Management System Awareness & Interpretation
 
Competency Requirements (Education, Training and Experience):
1. Candidate must posess at least a Bachelor's Degree of Engineering / Chemical or its equivalent
2. 2 years of working experience in Quality Syatem

Perks & Benefits

• Allowance (travel stipends, transportation, etc.)

Compliance

•Ensure processes and practices comply with ISO9001, ISO45001, ISO 14001 and ISO 17025 to the

compliance to ISO.

•Ensure processes and practices comply with Local regulations such as DOSH and DOE requirements.

•Act as an internal auditor, carry out internal check on all department from time to time. Document all

finding(s) and follow up with responsible parties.

•Perform audit on suppliers and vendor together with subject matter experts and supply chain. Provide

recommendation report based on the audit finding(s).

Quality

•Carry out calibration program for all QC equipment from prompting operation team for calibration, liaise with calibration service provider, to record keeping of QC equipment.

•Create and review Inspection Test Plan in accordance to the agreed/ project specific Application Procedure Specification.

•Customer Key contact person for Quality related enquiry

•Coordinator of Non-Conformance Report and Root Cause Analysis

•Prepare and issue Certificate of Conformity, Material Record Book, and other related document to

complete the documentation for client.

•Enforce and comply to all quality requirements.

•Understanding test requirement to relevant material in specified ISO.

HSE

•Coordinator of HSE investigation.

•With the help from Subject Matter Expert, perform Risk Assessment, HIRARC, and EAIA.

•Enforce and comply to all Health, Safety, and Environmental requirements.

Document Control

•Control the revision of company document.

•To control distribution of document to internal and external parties.

Other duties as assigned.

1) Working Days/Hours: Monday – Friday (8.00 am – 5.33 pm)

2) Transport Allowance (Executive)

3) Annual leave 16days (1st year, prorated)

4) Sick Leave 14days

5) The Company will provide you Outpatient treatment through our Company’s panel doctors, subject to medical fee claimable capped maximum of RM1,000.00 per calendar year. Employee can utilize the said amount for Dental and optical after confirmation (probation) if not claim as outpatient treatment.

6) Group Personal Accident Insurance

7) Group Term Life and Critical Illness

8) EPF, SOCSO, EIS, HRDC

Job Description : -

• Assist in the day-to-day project planning and implementation and report to Project Manager
• Ensure that all works (including those of sub-contractors) are carried out based on established method statements / procedures, QA/QC specifications and contract requirements.
• Liaise with authorities, consultants, contractors and subcontractors to ensure smooth implementation and on time delivery of the project.
• Manage project from inception until handover within the agreed costs, time and quality.
• Review and control all consultants' drawings to ensure consistency with the design.
• Review quality of construction material at site and ensure compliance with project quality plan (PQP) & specifications.
• Prepare PQP, QA/QC documents & perform risk assessment, site observation, non compliance report, Inspection Test Plan & other QA/QC task requirements at project site.
• Plan, coordinate, manage & supervise project teams on the Implementation of QA/QC programs and ensure adherence to required standards & procedures.
• Liaise with project teams, contractors, subcontractors & relevant authorities on quality related matters.

Requirements :-

• Candidate must possess at least Bachelor's Degree/Post Graduate Diploma/Professional Degree in Engineering (Civil).
• At least 3 Year(s) of working experience in the related field is required for this position or has any one of followings ;
• 1. Minimum 2 years relevant experience in the implementation of MS ISO 9001 in the construction industry, or
• Has attended field internal audit activities for MS ISO 9001, orPossesses Internal Audit Certificate from agency or body recognized by MAMPU
• • Required Skill(s): Strong interpersonal and communication skills, familiar with Auto Cad / Microsoft Project is an advantage, self-motivated eager to learn and is flexible & good observation.

Perks & Benefits

• Open culture
• Personal development opportunities

職位說明 ： -

• 協助日常專案規劃和實施，並向專案經理報告。
• 確保所有工作（包括分包商的工作）均按照既定的方法說明/程序、品質保證/品質控制規範和合約要求進行。
• 與相關部門、顧問、承包商和分包商聯絡，以確保專案順利實施並按時交付。
• 從專案啟動到專案交付，在約定的成本、時間和品質範圍內管理專案。
• 審核並控制所有顧問的圖紙，以確保與設計保持一致。
• 現場檢查建築材料質量，確保符合專案品質計畫（PQP）和規範。
• 準備 PQP、QA/QC 文件，並在專案現場進行風險評估、現場觀察、不合規報告、檢驗測試計劃及其他 QA/QC 任務要求。
• 規劃、協調、管理和監督專案團隊實施品質保證/品質控制計劃，並確保遵守所需的標準和程序。
• 就品質相關事宜與專案團隊、承包商、分包商及相關部門進行溝通協調。

要求 ：-

• 應徵者必須至少擁有工程（土木）專業的學士學位/研究生文憑/專業學位。
• 應徵此職位至少需要 3 年相關領域的工作經驗，或具備以下任一條件：
• 1. 至少2年建築業實施MS ISO 9001的相關經驗，或
• 曾參與 MS ISO 9001 的現場內部審核活動，或持有 MAMPU 認可的機構或團體頒發的內部審核員證書。
• • 必備技能：較強的人際溝通與溝通能力，熟悉Auto Cad/Microsoft Project者優先，積極主動，渴望學習，靈活且觀察力強。

福利待遇

• 開放文化
• 個人發展機會

職位說明 ： -

• 協助日常專案規劃和實施，並向專案經理報告。
• 確保所有工作（包括分包商的工作）均按照既定的方法說明/程序、品質保證/品質控制規範和合約要求進行。
• 與相關部門、顧問、承包商和分包商聯絡，以確保專案順利實施並按時交付。
• 從專案啟動到專案交付，在約定的成本、時間和品質範圍內管理專案。
• 審核並控制所有顧問的圖紙，以確保與設計保持一致。
• 現場檢查建築材料質量，確保符合專案品質計畫（PQP）和規範。
• 準備 PQP、QA/QC 文件，並在專案現場進行風險評估、現場觀察、不合規報告、檢驗測試計劃及其他 QA/QC 任務要求。
• 規劃、協調、管理和監督專案團隊實施品質保證/品質控制計劃，並確保遵守所需的標準和程序。
• 就品質相關事宜與專案團隊、承包商、分包商及相關部門進行溝通協調。

要求 ：-

• 應徵者必須至少擁有工程（土木）專業的學士學位/研究生文憑/專業學位。
• 應徵此職位至少需要 3 年相關領域的工作經驗，或具備以下任一條件：
• 1. 至少2年建築業實施MS ISO 9001的相關經驗，或
• 曾參與 MS ISO 9001 的現場內部審核活動，或持有 MAMPU 認可的機構或團體頒發的內部審核員證書。
• • 必備技能：較強的人際溝通與溝通能力，熟悉Auto Cad/Microsoft Project者優先，積極主動，渴望學習，靈活且觀察力強。

福利待遇

• 開放文化
• 個人發展機會

SUMMARY:

The Training and Quality Assurance Officer is responsible for ensuring the company maintains and adheres to vehicle engineering maintenance policies, procedures & standards and effectively monitors adherence through regular audits to ensure compliance as well as providing an engineering training service to the Singapore engineering function and assisting in the specification of new vehicles and components, working with the manufacturers to ensure the correct product is delivered on time, to specification and is fit for purpose. The role requires close liaison with staff members at all levels across the business and with the Land Transport Authority (LTA) approved assessors and auditors.

PRINCIPAL RESPONSIBILITIES AND AUTHORITIES:

• Support the business, particularly the Engineering Director, with engineering compliance, Health and Safety and vehicle maintenance audit requirements;
• Coordinate an on-going schedule of internal engineering maintenance audits centred on monitoring compliance with LTA requirements;
• Provide the senior executive with regular updates on engineering maintenance audit reports, and if issues exist adopt a supportive and coaching approach to ensure that issues are rectified and to prevent recurrence;
• Perform follow-up audits to ensure audit recommendations have been implemented;
• Work with purchasing staff to establish quality requirements from external suppliers;
• Ensure vehicle inspection and repair processes meet international and national standards;
• Identify ways to reduce waste and increase efficiency;
• Monitor performance by gathering relevant data and producing statistical reports;
• Generate and publish reports that summarise engineering maintenance compliance audit findings, safety issues and contractor performance as well as identify any key issues that need to be brought to management’s attention;
• Generate, develop and integrate preventative maintenance and servicing schedules;
• Identify technical issues arising from operational experience and generate solutions either internally or through the vehicle manufacturer;
• Conduct complete cost analysis investigations identifying and implementing improvements including (but not limited to) monitoring the life span of high value units and analysis of early life failures;
• Devise, review and continuously update vehicle diagnostic procedures, work systems and overhaul procedures;
• Identify training requirements covering new technology at both depot shop floor and management level. This will involve supporting the implementation and delivery of training across the business;
• Responsible for producing monthly management reports summarising breaches of engineering compliance, safety issues, and identifying key issues that need to be brought to management’s attention;
• Provide technical support and guidance to front-line engineering to resolve vehicle problems;
• Establish and maintain provision of correct tooling and diagnostic equipment best suited for the depot staff and technician use. Ensure provision of training in the use of the equipment and provide front-line support as required by users of the tools and equipment;
• Support the accreditation of the ISO standards within the business;

Specification and Parts Quality

• Understand the business requirements of Singapore specification buses;
• Liaise with vehicle manufacturers and suppliers on matters related to reliability and quality; and
• Work closely with the Engineering Manager to ensure that buses and their component parts are performing to specification at acceptable cost.

Quality Management Standards

• Have a working knowledge of quality management standards;
• Undertake audits at Tower Transit Singapore;
• Follow up on non-conformance and assist in providing compliance solutions; and
• Liaise with external qualification bodies and assist as necessary in their audits.

REQUIREMENTS:

• Degree in Mechanical Engineering or equivalent with at least 2 years of engineering audit experience in an automotive industry or a Diploma with at least 5 years experience.
• Flexibility in working hours to ensure commitments to operational requirements are fulfilled;
• Remain up to date with any new engineering or health and safety legislation, or policy that may affect the working environment or vehicle maintenance regime;
• Appropriate trades qualifications;
• Experience and thorough knowledge of bus maintenance;
• Qualified Auditor;
• Experience working at a senior compliance/audit level ideally within the transport industry with a demonstrated track record of results;
• Demonstrated leadership and motivation skills;
• Build strong working relationships both internally and externally;
• Strong communication skills, both written and oral, with ability and confidence to undertake group presentations;
• Computer literate with relevant experience in diagnostics and repair software;
• Understanding or a willingness to learn bus depot operational procedures and working practices; and
• Candidate with ACTA certification would preferred.

Responsibilities:

• Maintain accurate and up-to-date ISO 9001, ISO 14001, and ISO 13485 documentation, including Quality Manuals, procedures, work instructions, and records, to ensure system compliance and management review readiness.
• Plan, coordinate, and conduct internal and external audits to ensure organizational readiness for third-party certification, management reviews, and customer audits.
• Collaborate with internal stakeholders to support and participate in customer and supplier audits to ensure compliance requirements are met.
• Review audit findings, develop corrective action plans, and drive continuous improvement initiatives.
• Generate and review supplier quality performance reports, work closely with suppliers to resolve non-conformances, and promote continuous improvement.
• Issue, monitor, and follow up on Supplier Corrective Action Requests (SCAR), ensuring effectiveness and timely closure.
• Support qualification and onboarding of new suppliers to maintain a robust pipeline aligned with production requirements.
• Manage calibration schedules and preventive maintenance programs for equipment to ensure operational reliability and compliance.
• Address quality issues arising from production and customer feedback by working closely with production teams to implement corrective actions and resolve customer complaints with proper documentation.
• Ensure timely closure of Corrective and Preventive Actions (CAPA), non-conformance reports, and customer complaints, and publish quality performance reports.
• Lead Material Review Board (MRB) meetings with cross-functional teams to perform root cause analysis, implement corrective actions, and verify effectiveness.
• Supervise and lead QC inspectors to ensure parts inspection compliance with engineering drawings and quality standards.

Qualifications:

• Diploma in Quality Management, Engineering, Manufacturing, or a related field.
• Min 3 years of relevant experience in quality or manufacturing environments, with exposure to audits and documentation.
• Basic understanding of supplier management and quality coordination.
• Familiarity with commonly used quality management standards (e.g. ISO systems).
• Working knowledge of quality tools and process control methods.

We regret only shortlisted candidates will be contacted. All applications will be handled confidentially. By submitting your application, you agree to the collection, use, retention, and disclosure of your personal information to prospective employers.

Wecruit Pte Ltd

EA License No: 20C0270

EA Personnel: Nyon Hock Sen (Aden)

EA Personnel Reg No: R24124070

Responsibilities:

• Handle customer complaints, returns, and improvement requests; monitor progress and ensure efficient resolution.
• Coordinate customer audits, QA visits, and surveys, including follow-up activities to address findings.
• Manage customer requests and maintain relevant customer satisfaction metrics.
• Collaborate with cross-functional teams to resolve quality issues and meet customer requirements, driving product quality improvements.
  

Requirements:

• Minimum Bachelor's degree in Electronics Engineering, Electrical Engineering, Material Science, Chemistry and Physics.
• Basic understanding of semiconductor technology.
• >3 years’ relevant experience in module process/integration and/or quality field handling customer.
• Knowledge of problem solving (8D methodology), statistical techniques, production part approval process (PPAP) and planning/project management is an advantage
• Knowledge of ISO9001/ISO/TS16949 or VDA6.3 standards and audit handling/experience is preferred
• Strong project management skills and ability to plan effectively.
• Excellent communication and negotiation skills; capable of effective collaboration with external partners and customers.
• Proficiency in presentation skills.

Job Responsibilities:

• Plan and implement the Abnormal Handling (ABS/PAR/IEAR/BPD) system, assisting the FAB reviewing process abnormalities establishing an early warning notification system, with the aim of reducing quality loss and cost for the company and customers, and supervising the effectiveness of system execution.

• Plan and implement the MRB (Material Review Board), assisting the FAB reviewing waived products resulting from process abnormalities, in order to reduce quality loss and cost for the company and customers, and supervising the effectiveness of the system.

• Plan and implement internal audits, assisting the FAB in identifying processes and systems with quality risks, and supervising the effectiveness of improvements to risk processes.

• Plan and implement the MSA (Measurement System Analysis) system, assisting the FAB in performing calibration and capability assessment of measuring instruments to ensure the reliability of measurement values and thus ensure product quality.

• Implement the automotive service package, assisting the FAB in planning executable methods and systems, and auditing and supervising the execution process for automotive products.

Job Requirements:

• Minimum Bachelor degree in engineering (ex. Electronics, Material science, Chemistry, Physics, Statistics, Data Science, Math)

• Candidates with more than 3 years of semiconductor process/quality/integration experience will be considered for a senior role

• Knowledge of problem solving (8D methodology), statistical techniques, Measurement System Analysis(MSA) and planning/project management is an advantage

• Knowledge of ISO9001/ISO/TS16949 or VDA6.3 standards, Lead Auditor qualification and audit handling/experience is preferred

• Collaborate with cross-functional teams to resolve quality issues and customer requirements to drive product quality improvements

• Good communication and negotiation skills, with the ability to collaborate with FAB module, PEI and Customers

Whether you’re looking for your first role or your next career move, UMC is where your future can take shape.

Step into your future with us. Apply Now.

About United Microelectronics Corporation

United Microelectronics Corporation (UMC) is a leading global semiconductor foundry with over 40 years of innovation powering technologies across AI, automotive, consumer electronics, connectivity, and IoT. As one of the industry’s most established players, we enable breakthrough technologies through precision-engineered semiconductor manufacturing for customers across every major sector of the electronics world.

Headquartered in Taiwan, UMC has been present in Singapore since 2004 and continues to invest in local talent, technology, and advanced manufacturing. Our recent Fab expansion reflects our long-term commitment to building Singapore as a key hub for semiconductor innovation, and to creating stable, meaningful careers through innovation, teamwork, and progress.

Join a team that invests in your future from day one. With best-in-class training, hands-on experience and access to cutting-edge tools, UMC equips you to lead tomorrow’s tech landscape, right down to the nanometre.

Overall Responsibilities

• Assist the Manager, QA in daily running of the department, ensuring daily checks are in place and that necessary quality, safety and compliance are adhered to

Duties & Responsibilities

• Ensure that daily quality and safety checks are in place, checklists completed and submitted to reporting officer for reference and follow-up
• Execute and monitor procedures related to daily production
• Monitor process flows and ensure its compliance to established parameters
• Evaluate the services of sub-contracted service, for example pest control, cleaning contractors, etc
• Plan and monitor shelf-life studies for current and new products
• Attend daily briefing with operation and action plan for improvement
• Assist with customer complaints or feedback and when microbiological limits have been deviated
• Conduct FSSC and ISO 22000, GMP and local food authorities’ requirements (SFA/MUIS/NEA) training for relevant staff
• Assist reporting officer in pest control routines
• Implement Workplace Safety and Health initiatives planned by QA & Compliance Manager
• Carry out other administrative and operational-related duties in and support the QA & Compliance Department
• Conduct risk assessment profiling for products, ingredients and product contact materials
• Any other duties assigned by reporting officer or Head of Department

Requirements:

• Diploma/Degree in Food Science and Technology, Food Nutrition and Dietetics
• Completed ISO, FSSC, HACCP and/or Risk Management course
• Candidates with 1 to 2 years of experience in a food manufacturing environment will be an added advantage
• Experience in ISO, HACCP, Risk Management and GMP is an advantage
• Proactive, resourceful and adaptable
• Ability to multi-task and work under pressure
• Good communications, interpersonal and team interaction skills
• Good diplomacy (to liaise with external parties such as SFA customers, vendors and other government
• Fresh graduates are welcome to apply, and training will be provided.

Job Summary
Responsible for strengthening and maintaining a consistent Quality Management System across affiliates in the Asian region, while coordinating with global, regional, and local stakeholders to ensure effective implementation and operational alignment.

Key Accountabilities
1)      Design and oversee risk-based GMP/GDP audit programs covering Asian LA (Sales sites and Manufacturing sites) 

2)      Review and approve local SOPs to ensure alignment with PIC/S GMP and Global SOPs. 

3)      Design and deliver regional QA training programs (including not only QA-related skill development but also career development program such as organizational management and mindset-building skills) and evaluate training effectiveness for Asian LA (Sales sites and Manufacturing sites). 

4)      Establishment and monitoring of common quality related KPIs for Asian LA (Sales sites and Manufacturing sites), and lead continuous improvement activities (e.g. Leading Asian Management Review Meeting) utilizing these KPIs.

5)      Oversee introduction and operation of GMP-related computerized systems owned by Global Quality for Asian LA (Sales sites and Manufacturing sites)

6)      Identification of QA related challenges and indication of solutions through establishment and operation of regular/ad-hoc communication with QA members in Asian LA (Sales Sites and Manufacturing Sites)

7)      Ensure effective end-to-end change management across manufacturing, regulatory, and supply chain functions. 

8)      Lead quality issue management, including deviations, complaints, supply impact assessment, and recall risk escalation. 

9)      Operation of the RHQ organization, including setting and managing team policies and objectives; securing and developing resources required for business execution; establishing opportunities for communication with stakeholders; planning and implementing operational improvements; and maintaining and improving the workplace environment.

Qualifications / Required

• Master’s degree in pharmacy, physics, or chemistry. Pharmacist license is preferred.
• Extensive experience in GMP/GDP audits, including CAPA review and effectiveness evaluation. 
• Strong understanding of PIC/S GMP, ICH Q7, ICH Q9, and ICH Q10 and QA operation experience (more than 15 years)
• Experience as a QA lead during regulatory inspections. 
• Ability to design risk-based audit and quality KPI frameworks. 
• Proven capability in SOP harmonization and document control using globalized computerized systems. 
• Experience in QA training design, auditor development, and training effectiveness evaluation (e.g., Kirkpatrick model). 
• Strong English/Japanese communication skills for meetings, documentation, and executive reporting. 
• Knowledge of CSV, data integrity, and GMP computerized system implementation. 
• Experience in cross-functional leadership, and organizational management in multicultural environments, including the following:

1. Experience in identifying required skills and competencies by back casting from organizational objectives
2. Experience in defining recruitment requirements (Job Descriptions), participating in candidate selection, and designing onboarding processes
3. Experience in succession planning with a focus on key roles and successor development
4. Experience in designing role- and level-based training frameworks (e.g., Technical, Leadership, Compliance)
5. Ability to design communication strategies that take into account on-site resistance and cultural gaps
6. Experience in cross-functional collaboration with multiple disciplines (e.g., QA, RA, Manufacturing, HR)
7. Ability to clearly explain proposals and build alignment with executive and senior management
   

Preferred
Project management experience involving affiliates located in multiple countries; Project Management Professional (PMP) or equivalent qualification preferred.