Country Clinical Quality Manager

5 months ago


Selangor, Malaysia Fortrea Full time

Responsibility for the annual country specific QC plan, monitoring, and coordinating the implementation, and execution of QC plan in the respective country/US region according to the Client Standard Operating Procedures and ICH Guidelines and GCP.
- Responsibility for the management of the Client Corrective and Preventive actions (CAPA) of GCP audits and inspections in the country/US region at the Client level according to the Client Standard Operating Procedures and ICH Guidelines and GCP
- Responsibility for the annual country specific quality plan, monitoring, and coordinating the implementation and execution of QC in the respective country/region
- Responsibility to manage and/or co-lead key Client initiative charged with executing the continuous improvement.
- CCQM identifies local as well as global process improvement opportunities and training needs, and will be the local point of contact for all stakeholders ensuring appropriate training is implemented
- The role requires the ability to follow current processes and procedures of the Client but also the ability to improve processes and procedures
- This position has a significant impact on the ability to conduct clinical trials in accordance with external and internal regulations and guidelines of the Client

On the Client level:

- ICH Guidance and GCP Regulations, Country Client SOPs: Is an expert at local level.
- Local Lead for Management of the Client Country Standard Operation Procedures (CSOP).
- In cooperation with country functional area heads: ensures the Client CSOPs are checked/updated regularly; signs/authorizes CSOP deviations along with process owner.
- Responsible for all aspects of the quality site management as prescribed in the project plans
- Local Quality and Process Improvement and training contact person
- identifies local training demand, initiate local training needs and activities.
- Defines an annual country QC plan with collaboration to regional CQM
- With mutual agreement with the functional areas will perform quality control (QC) activities and visits. Support on resolution of quality issues
- Responsible for management and support audit preparation activities. In cooperation with country functional area person initiate state of the art root cause analysis for audit and inspection findings
- Responsible for country trend analysis and impact assessments of audits and/or inspection findings

**Experience**:

- Minimum Required:_
- Minimum of six-eight (6-8) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits)
- Deep knowledge and understanding of Clinical Trial processes and quality management tools
- Demonstrated experience leading cross-functional teams of business professional
- Ability to proficiently interact with all levels of clinical research management and exert influence to achieve results
- Excellent site monitoring skills
- Excellent study site management skills
- Ability to work with mínimal supervision
- Good planning and organization skills
- Good computer skills with good working knowledge of a range of computer packages
- Excellent verbal and written communication skills
- Ability to train and supervise junior staff
- Ability to resolve project-related problems and prioritizes workload for self and team
- Ability to work within a project team
- Works efficiently and effectively in a matrix environment

Education/Qualifications
- Minimum Required:_
- University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
- Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
- Thorough understanding of the drug development process
- Fluent in local office language and in English, both written and verbal

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit


Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identi



  • Selangor, Malaysia Fortrea Full time

    Essential Job Duties: These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties. - PERFORMANCE: Accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Client policies and...


  • Selangor, Malaysia Sandoz Full time

    **Your Key Responsibilities**: Your responsibilities include, but not limited to: - Building strong relationships with relevant functions in the affiliate organization (including but not limited to regulatory affairs, medical affairs, quality assurance, marketing and sales, clinical development and others), in collaboration with the Director/ Associate...

  • Clinical Team Lead

    5 months ago


    Selangor, Malaysia Fortrea Full time

    The Clinical Team Lead (CTL) is responsible and accountable for the driving the delivery of the clinical deliverables, acting within the Clinical Project Management (CPM) role within the Core Team or supporting the CPM, as assigned. The CTL is responsible for working cross functionally, within a matrix environment, to ensure successful execution of the trial...

  • Clinic Supervisor

    6 months ago


    Hulu Selangor, Malaysia Prevent Plus Sdn Bhd Full time

    **URGENT HIRING!!! URGENT HIRING!!! URGENT HIRING!!!** **Job Title: Clinic Supervisor/Clinic Assistant** **Industry: Healthcare** **Years of Working Experience: Preferred 1 year of experience in any related field.** We are seeking a motivated and detail-oriented individual to join our healthcare team as a Clinic Supervisor/Clinic Assistant. You will be...

  • Quality Manager

    5 months ago


    Selangor, Malaysia Eaton Full time

    **What you’ll do**: This position is responsible for leading the development, execution and deployment of the Quality Management System of Eaton-SIAEC JV in Malaysia in conjunction with plant leadership. Provides Total Quality Leadership to customers, suppliers, partners and internal manufacturing cells. Leads continuous improvement activities in targeted...

  • Clinical Specialist

    5 months ago


    Selangor, Malaysia Embecta Full time

    embecta is one of the largest pure-play diabetes care companies in the world, leveraging its nearly 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of approximately 2,000 employees around the globe. For more information, visit or follow our social channels...

  • Human Resources

    6 months ago


    Hulu Selangor, Malaysia INDUSTRIAL QUALITY MANAGEMENT SDN BHD Full time

    1. Engage mostly in the pre-hiring recruitment process such as interviews arrangement, interviews with hiring managers, and HR Managers in their respective pillars. 2. Handling and responsible for Recruitment, Orientation, and onboarding of new employees. 4. Maintain and update staff’s movement and all relevant details in our staff personnel files. 5....

  • Staff Nurse

    5 months ago


    Hulu Selangor, Malaysia Careclinics Healthcare Services Sdn Bhd Full time

    **Primary Purpose and Scope** - Assist doctors and nurses in basic clinical tasks to ensure a high level of operational efficiency - Patient registration, prescriptions preparation, dispensing medicines - Coordinate patient care at the clinic. - Order and keep stock of medication and manage clinic tasks - Manage daily clinic operations, filing system, and...

  • Product Manager

    5 months ago


    Selangor, Malaysia Embecta Full time

    embecta is one of the largest pure-play diabetes care companies in the world, leveraging its nearly 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of approximately 2,000 employees around the globe. For more information, visit or follow our social channels...

  • Quality Coordinator

    6 months ago


    Selangor, Malaysia Ingenious Job Full time

    Category: - Customer Services - Industry: - Engineering - Electrical / Electronic / Mechanical - Location: - Plaza 33 - Selangor - Education: - Bachelor Degree - Country: - Malaysia - Salary Range: - 3000.00-4000.00 - Experience(Min): - Fresh Graduate/No experience - Job Type: - Full Time Contractual- Requirement: - Degree/ Diploma in Engineering or...

  • Quality Assurance

    5 months ago


    Selangor, Malaysia Wrightbus (Malaysia) Sdn Bhd Full time

    **Purpose of Post**: To develop and maintain the Quality Management System (QMS) across the Company through existing and new procedures, and to regulate, control and improve the quality of manufacturing designs, processes and the final product. **Key Tasks**: - Implement and maintain all relevant procedures described in the Quality Management System...


  • Selangor, Malaysia Sandoz Full time

    **Your Key Responsibilities**: Your responsibilities include, but not limited to: - Ensure the local management of adverse event information, in collaboration with 3rd party vendors. - Ensure exchange and reconciliation of product complaints associated with adverse events. - Contribute to the planning of periodic reports to meet local compliance...


  • Selangor, Malaysia DHL Full time

    DHL Group is the logistics provider of the world with over 580,000 employees in more than 220 countries and territories. We are an organization that is not just moving goods around, we have a very clear purpose**:Connecting People. Improving Lives.** At DHL, people mean the world to us. That’s why our goal has always been to attract and retain the best...


  • Selangor, Malaysia Philip Morris International Full time

    BE A PART OF A REVOLUTIONARY CHANGE At PMI, we’ve chosen to do something incredible. We’re totally transforming our business and building our future on one clear purpose - to deliver a smoke-free future. With huge change, comes huge opportunity. So, wherever you join us, you’ll enjoy the freedom to dream up and deliver better brighter solutions and...

  • Quality Administrator

    5 months ago


    Selangor, Malaysia Wrightbus (Malaysia) Sdn Bhd Full time

    **Key Tasks**: 1. Update data on a daily and weekly basis. 2. Create and maintain registers, logs and databases 3. Update and upload documentation to Sharepoint System 4. Ensure data is displayed in multiple locations around the factory 5. Communicate with personnel at all levels, internally and externally to the company, in relation to quality...

  • Sales Consultant

    5 months ago


    Selangor, Malaysia ECRI Berhad Full time

    The individual in this role will represent ECRI to a diverse clientele throughout the Asia Pacific region. Your primary responsibility will be to spearhead the development and execution of strategies and initiatives aimed at effectively delivering our value proposition in each country. This includes offering consultancy services, training programs, and...


  • Hulu Selangor, Malaysia APM Plastics Sdn Bhd Full time

    1. To take effective role, lead and control of Quality department function and operation. 2. To ensure all employees comply to Quality management system (IATF, ISO 9001 and ISO 14001) as well as customer specific requirement, by adhering to the company's Quality and Environmental, Health and Safety (EHS) policy and procedures, and helping to achieve...

  • Project Manager

    7 months ago


    Selangor, Malaysia The Church of Jesus Christ of Latter-day Saints Full time

    The position is responsible for the construction of assigned projects in the countries/regions within the Asia Area. Projects include new meetinghouses, additions, large replacements and improvements, and lease buildouts that provide places of worship where all feel loved and can build faith in Jesus Christ. - Assist the Area Architecture, Engineering, and...

  • Quality Controller

    5 months ago


    Hulu Selangor, Malaysia SELASIH AMAN SDN BHD Full time

    1. Check qualty of eggs delivered to the customers 2. Response to customer complaint 3. Monitor eggs quality 4. Monitor eggs movement in and out of store 5. Supervise operations and eggs collection 6. Handling audits and customers audits 7. Prepare production report, aging report and stock report 8. Involve and handling laboratory and test for eggs...


  • Selangor, Malaysia Alcon Full time

    Ensure the required regulatory reports are submitted complete and on-time - Follow-up as needed with internal functions and regulatory agencies, to gather missing/required information to ensure compliance to requirements - Perform investigation for any late reporting, determine root-cause and implement required actions - Own the process, drive improvements...