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Jobs or company...

Program Director (Global Product Transfer)

RM 18,000 - RM 28,000 / month
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Responsibilities:

  • Responsible for ensuring that all product transfers are executed on time, within scope, and in full compliance with regulatory requirements. This is a leadership position that requires both technical expertise and strong program management skills.

Product Transfer Leadership: Lead and manage the end-to-end product transfer process for new and existing medical devices, ensuring successful commercialization and scaling of products in a manufacturing environment. Oversee the technical, quality, and regulatory aspects of the transfer to ensure a smooth transition.

Cross-functional Team Management: Work closely with R&D, engineering, regulatory affairs, quality assurance, manufacturing, and supply chain teams to drive product transfers. Lead cross-functional teams to align on key deliverables, timelines, and resources for successful product launches.

Regulatory Compliance & Quality Management: Ensure all product transfers adhere to FDA, ISO 13485, and other relevant regulatory standards. Monitor the implementation of quality control and assurance systems during the transfer process to ensure products meet the highest safety and performance standards.

Process Optimization & Improvement: Identify and implement process improvements to ensure efficient and cost-effective product transfers. Collaborate with engineering and manufacturing teams to enhance manufacturing processes, optimize production workflows, and resolve any technical challenges that may arise during the transfer process.

Risk Management & Mitigation: Proactively identify risks related to product transfers, including potential delays, quality issues, and resource constraints. Develop and implement risk mitigation strategies to address and resolve any challenges promptly.

Program Planning & Scheduling: Develop and manage detailed program plans, timelines, and deliverables for product transfer projects. Ensure milestones are met and that resources are allocated appropriately to avoid bottlenecks and delays.

Stakeholder Communication: Serve as the primary point of contact for senior leadership, clients, and other stakeholders regarding the status of product transfer projects. Provide regular updates on progress, key challenges, and corrective actions being taken.

Vendor & Supplier Management: Manage relationships with external suppliers and vendors involved in the product transfer process, ensuring that they meet quality standards, regulatory requirements, and delivery timelines.

Training & Support: Ensure that manufacturing teams are adequately trained on new product lines and manufacturing processes. Provide ongoing support and troubleshooting during the initial production runs to ensure successful scaling.

Leadership & Team Development: Lead, mentor, and support program managers and cross-functional team members involved in product transfer projects. Foster a collaborative environment and encourage continuous learning and development.

Qualifications:

· Bachelor’s degree in Engineering, Life Sciences, or a related field (Master’s preferred).

· Minimum 12-15 years of experience in program management within the medical device or regulated manufacturing industry, with a focus on product transfer or new product introduction (NPI).

· Proven experience in leading cross-functional teams through successful product transfers, ideally in the medical device manufacturing space.

· Strong understanding of regulatory requirements and industry standards (FDA, ISO 13485, CE marking) related to medical devices.

· Exceptional leadership skills with the ability to influence and motivate teams across different functions.

· Strong problem-solving abilities, with a proactive approach to identifying risks and developing mitigation plans.

· Experience in optimizing manufacturing processes and driving continuous improvement initiatives.

· Excellent communication skills, both written and verbal, with the ability to engage stakeholders at all levels of the organization.

· Proficient in project management tools (MS Project, Jira, etc.), and familiar with data analysis tools (Excel, Power BI).

· PMP, Lean, Six Sigma, or other relevant certifications are a plus.

· SAP system experience.

· Experience with global product transfers, including working with international manufacturing sites.

· In-depth knowledge of medical device manufacturing processes such as assembly, packaging, sterilization, and quality control.

Job Type: Permanent

Pay: RM18,000.00 - RM28,000.00 per month

Supplemental Pay:

  • 13th month salary
  • Performance bonus

Education:

  • Bachelor's (Preferred)

Experience:

  • Program Management: 10 years (Preferred)
  • Medical equipment or devices: 10 years (Preferred)
  • product transfer: 8 years (Preferred)

Work Location: In person