Site General Manager – Medical Device CDMO (Malaysia)

Role Overview

The Site General Manager is responsible for the full leadership and performance of a Malaysia-based Medical Device CDMO manufacturing site. This role ensures compliant, high-quality, and cost-effective delivery of contract development and manufacturing services to global customers. The GM will drive operational excellence while ensuring strict adherence to regulatory standards (FDA, ISO 13485, GMP), customer requirements, and industry best practices. As the senior site leader, the position plays a critical role in customer engagement, business growth, and capability expansion.

Key Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Key Qualifications & Experience

• 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.

Key Competencies

• Regulatory and quality excellence mindset
• Customer-centric leadership
• Strategic and commercial acumen
• Strong operational and financial management
• Change leadership and transformation capability
• Executive communication and stakeholder influence
• Results-driven with high accountability

Working Location

Johor, Malaysia