Job Description Summary

Job Description Summary
A project manager is a professional who executes and leads a team through the project life cycle by planning, budgeting, scheduling and tracking a project plan. The project plan thoroughly explains how the project will be executed and includes a budget, timeline, schedule, roles and responsibilities among other things.

Project managers play the lead role in planning, executing, monitoring, controlling, and closing out projects. They are accountable for the entire project scope, the project team and resources, the project budget, and the success or failure of the project.

Job Description

M2-14096

• Project Planning

• Define project scope, goals, and deliverables.
• Develop detailed project plans, schedules, and resource allocation.
• Identify key milestones and deadlines.

• Team Coordination

• Assign tasks and responsibilities to team members.
• Facilitate communication and collaboration among stakeholders.
• Resolve conflicts and ensure team alignment.

• Budget and Resource Management

• Estimate costs and manage the project budget.
• Allocate resources efficiently (people, tools, materials).
• Monitor expenditures and adjust plans as needed.

• Risk Management

• Identify potential risks and issues.
• Develop mitigation and contingency plans.
• Monitor and respond to risks throughout the project lifecycle.

• Stakeholder Communication

• Serve as the main point of contact for stakeholders.
• Provide regular updates on project status, progress, and challenges.
• Manage expectations and ensure stakeholder satisfaction.

• Quality Assurance

• Ensure deliverables meet quality standards and requirements.
• Conduct reviews, testing, and validation.
• Implement corrective actions when needed.

• Monitoring and Reporting

• Track project progress using KPIs and performance metrics.
• Prepare status reports and dashboards.
• Adjust plans based on performance data.

• Project Closure

• Ensure all deliverables are completed and approved.
• Conduct post-project evaluations and lessons learned.
• Archive documentation and release resources.

Qualification

• Bachelor’s degree in engineering, Information Technology, Computer Science, or Business Administration.
• Additional training or certification in medical device regulations (e.g., ISO 13485, FDA 21 CFR Part 11) is a plus.
• Minimum 5–8 years of experience in project management, preferably in medical device, pharmaceutical, or regulated manufacturing environments.
• Proven track record of managing digital transformation, MES, or IT system implementation projects.
• Experience working with Apriso or other MES platforms is highly desirable.
• Strong skills in project planning, budgeting, resource allocation, and risk management.
• Ability to manage cross-functional teams and coordinate with internal departments (Quality, IT, Operations) and external vendors.
• Understanding of eDHR systems, data integrity, and system validation.
• Familiarity with GMP, ISO 13485, and FDA requirements for digital records and system compliance.
• Ability to support audits, documentation, and change control processes.
• Excellent stakeholder management and communication skills.
• Ability to lead meetings, resolve conflicts, and ensure team alignment.
• Skilled in preparing status reports, dashboards, and executive updates.
• Experience in quality assurance and performance tracking using KPIs.
• Ability to conduct post-project evaluations and implement lessons learned.

Required Skills

Optional Skills

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Primary Work Location

MYS Kedah - Bard Kulim (Malaysia)

Additional Locations

Work Shift

MY3 Normal 8a-4.45p Group 26 (Malaysia)