Operations Director / Head Of Operations

BACTIGUARD ( SOUTH EAST ASIA) SDN. BHD.; Seberang Perai; On-site; MYR 300,000 - 550,000; Full time

Job summary

Bactiguard (South East Asia) Sdn. Bhd. is seeking an Operations Director to provide strategic leadership for development, manufacturing, regulatory compliance, and regional growth in South East Asia.

You will oversee manufacturing, quality, regulatory, supply chain, IT, and engineering, driving Lean and Six Sigma to achieve safety, cost, and delivery KPIs while ensuring compliance with global standards.

Qualifications

• Educational requirements: Bachelor's degree; advanced degree preferred (MBA/PhD) in relevant fields.
• Experience: 15–20+ years in operational leadership, 5+ years as Director/Plant Manager/Head of Operations in regulated medical device/pharma environments.
• Proven track record in leading multi-disciplinary teams, scaling lean manufacturing, and global expansion.
• Experience defending automated lines during major regulatory audits (FDA/CE/MDR/ISO 13485).
• Strong financial, strategic, and stakeholder engagement skills.
• Collaborative coaching leadership while addressing compliance issues.

Responsibilities

• Define and implement the regional growth plan aligning with global strategies.
• Oversee day-to-day operations across SEA including manufacturing, quality, regulatory, supply chain, IT, and engineering.
• Drive Lean, Six Sigma, Kanban, 5S, and Visual Manufacturing to optimize plant performance.
• Ensure compliance with MDA, FDA, MDR, ISO 13485 and maintain audit readiness.
• Lead budgeting, forecasting, and resource allocation to support EBITDA targets.
• Mentor executives and build a high-performing leadership team.

Job description

Operations Director / Head Of Operations

Provide strategic leadership and executive oversight to ensure the successful development, manufacturing, regulatory compliance, of the product which drives the regional business growth, profitability, innovation, and world-class quality while maintaining an uncompromised commitment to regulatory, legal, and ethical standards of Bactiguard (South East Asia) Sdn. Bhd.

Key responsibilities

Define, implement, and communicate the company's strategic vision and regional growth plan, aligning short- and long-term business objectives with global corporate strategies and market trends

Oversee and direct all day-to-day operations across the South East Asia footprint, encompassing product development, high-volume manufacturing, quality assurance, regulatory affairs, supply chain logistics, IT, and engineering functions

Lead, direct, and optimize manufacturing activities to achieve plant KPIs across safety, quality, delivery, cost, and inventory management

Champion operational excellence by driving process improvements, Lean Manufacturing, Six Sigma, Kanban, 5S, and Visual Manufacturing frameworks to eliminate plant bottlenecks, maximize labor productivity, and reduce material scrap rates

Secure and maintain strict compliance with global and local regulatory standards, ensuring physical plants and operations continuously meet or exceed Malaysian Medical Device Authority (MDA) regulations, US FDA requirements, EU Medical Device Regulation (MDR), and ISO 13485 standards

Maintain a constant, plant-wide state of audit validation and readiness to successfully defend chemical processing and automated lines during stringent international notified body reviews and partner inspections

Lead the organization in upholding the highest performance standards for quality management systems (QMS), product certifications, and product safety

Enforce global Environmental, Health, and Safety (EHS) standards to ensure a secure, hazard-free, and sustainable working environment for all personnel

Direct and control the company's annual operational budget, financial forecasts, and resource allocation to support EBITDA targets and unit cost optimization

Build, mentor, and lead a high-performing executive and supervisory workforce, fostering a culture of innovation, accountability, continuous learning, and ethical conduct

About you

Required: Bachelor's degree from a four-year accredited institution

Preferred: Advanced degree (Master's or PhD) in Chemical Engineering, Biomedical Engineering, Biotechnology, Business Administration (MBA), or a related industrial management/life-sciences discipline

Minimum of 15 to 20+ years of progressive operational leadership experience, with at least 5 years serving at a Director, Plant Manager, or Head of Operations level within a highly regulated medical device (Class II/III) or pharmaceutical manufacturing environment

Proven track record (20+ total years preferred) of leading multi-disciplinary engineering and assembly workforces, scaling lean manufacturing facilities, and executing global business expansion

Deep hands-on experience defending automated lines and chemical processing during major international regulatory audits (e.g., US FDA 510(k)/PMA, CE Mark/EU MDR, ISO 13485)

Exceptional financial, operational, and commercial acumen with strong strategic thinking capabilities

Outstanding communication, stakeholder engagement, and negotiation skills

Adopts a collaborative, coaching leadership approach while retaining the professional courage to constructively challenge operational or compliance irregularities

Bactiguard (South East Asia) Sdn. Bhd. is a Swedish medical device company with a mission to save lives. To achieve this mission, we develop and supply infection prevention solutions which reduce the risk of healthcare associated infections and the use of antibiotics. In this way, we save significant costs for healthcare and the society at large.

Join us and be part of a company that innovates and provides patented technological solutions across the healthcare industry. We are a growing company, established in providing medical device solutions with a Mission to Save Lives, from hospitals, pharmacies, clinics, and patients.

Bactiguard (South East Asia) Sdn. Bhd. is a Swedish medical device company with a mission to save lives. To achieve this mission, we develop and supply infection prevention solutions which reduce the risk of healthcare associated infections and the use of antibiotics. In this way, we save significant costs for healthcare and the society at large.

Join us and be part of a company that innovates and provides patented technological solutions across the healthcare industry. We are a growing company, established in providing medical device solutions with a Mission to Save Lives, from hospitals, pharmacies, clinics, and patients.