全职 Site General Manager – Medical Device CDMO (Malaysia) 工作, 薪水 up to MYR 25,000, Hunters International Johor 公司招聘中 - Ricebowl

• Bachelor’s degree in Engineering, Life Sciences, or related discipline (Master’s preferred).

• 15+ years of experience in medical device or regulated manufacturing environments, with significant CDMO experience preferred.

• Minimum 5–8 years of senior leadership experience managing a full site or major business unit.

• Strong knowledge of FDA, ISO 13485, GMP, and medical device regulatory requirements.

• Proven success in customer-facing roles and managing complex customer programs.

• Experience in NPI, validation, and technology transfer within regulated environments.

• Familiarity with Malaysian regulatory and labor environment is advantageous.

1. End-to-End CDMO Operations Leadership

• Lead all site operations including manufacturing, engineering, NPI (New Product Introduction), and supply chain.

• Ensure consistent delivery of customer programs with high quality, on-time delivery, and cost efficiency.

• Oversee both development and commercial manufacturing activities, including scale-up and transfer projects.

• Drive operational KPIs such as OEE, yield, cycle time, scrap, and OTD.

2. Regulatory Compliance & Quality Excellence

• Ensure full compliance with global regulatory standards including FDA QSR (21 CFR Part 820), ISO 13485, GMP, and applicable local regulations.

• Foster a “quality-first” culture and ensure robust Quality Management System (QMS) execution.

• Oversee audit readiness and management of regulatory inspections and customer audits.

• Ensure effective CAPA, risk management (ISO 14971), and validation processes.

3. Customer & Program Management

• Act as the executive sponsor for key customer accounts.

• Partner with commercial and program management teams to ensure successful execution of customer projects.

• Support business development activities including site visits, audits, and technical capability presentations.

• Build strong, trust-based customer relationships to drive retention and growth.

4. Strategy, Growth & Financial Performance

• Develop and execute site strategy to support CDMO growth, including capability expansion and new technology adoption.

• Own full P&L responsibility, including budgeting, forecasting, and cost management.

• Drive profitable growth through operational efficiency, pricing support, and capacity optimization.

• Lead capital investment planning for new programs, equipment, and facility expansion.

5. New Product Introduction (NPI) & Technology Transfer

• Ensure successful transfer of products from R&D to manufacturing and from other global sites or customers.

• Establish scalable, validated manufacturing processes that meet regulatory and customer requirements.

• Drive cross-functional alignment to meet timelines, cost targets, and quality expectations.

6. Safety, Health & Environment (EHS)

• Champion a strong safety and compliance culture aligned with corporate and Malaysian regulatory standards.

• Ensure safe handling of materials and processes relevant to medical device manufacturing (including cleanroom environments).

• Lead sustainability and environmental initiatives.

7. Leadership & Talent Development

• Build and lead a high-performance, cross-functional leadership team.

• Develop critical capabilities in regulatory, engineering, and advanced manufacturing.

• Drive employee engagement, retention, and succession planning. • Promote a culture of accountability, collaboration, and continuous improvement.

8. Continuous Improvement & Operational Excellence

• Lead Lean, Six Sigma, and digital transformation initiatives across the site.

• Enhance process capability, reduce variability, and minimize waste.

• Drive automation, digital manufacturing, and Industry 4.0 initiatives where appropriate.

9. External & Stakeholder Engagement

• Represent the site with regulatory authorities, auditors, customers, and industry bodies.

• Establish strong relationships with local government agencies and partners.

• Ensure the site remains aligned with corporate governance and global standards.

• Annual Leave
• Medical and Hospitalisation Leave
• SOCSO
• EPF
• EIS
• Training Provided
• 5 Working Days