Operation Director

Private Advertiser; Simpang Ampat; On-site; MYR 180,000 - 320,000; Full time

Job summary

Private Advertiser in Penang is seeking an experienced Operation Director to oversee a pharmaceutical and medical devices manufacturing facility in Simpang Ampat. This full-time role drives operational excellence, regulatory compliance, and leadership across production, quality, supply chain and engineering to deliver world-class contract development and manufacturing services.

The successful candidate will have 10+ years of operations leadership in pharma or medical devices, with deep GMP/FDA

Qualifications

• Bachelor's degree in Pharmaceutical Sciences, Chemical Engineering, Business Administration, or related field.
• 10+ years of operations management experience in pharma manufacturing or medical devices.
• Progressively increasing responsibility in scheduling, materials, manufacturing and production control.
• Strong knowledge of GMP, FDA compliance and international regulatory frameworks.
• Lean manufacturing, process optimisation and continuous improvement expertise.
• Excellent leadership and people management skills with the ability to motivate and build teams.
• Strong financial acumen with budget management and cost control experience.
• Excellent problem-solving and strategic thinking abilities.
• Outstanding communication and stakeholder management capabilities.
• Proficiency in MRP/ERP systems and production management software.

Responsibilities

• Manage and direct the operations department, set and monitor performance goals aligned with global strategy.
• Develop and implement local operations processes and standardise world-wide processes.
• Negotiate major purchasing contracts and blanket orders within company policies.
• Review production schedules to ensure timely receipt and material availability.
• Analyze delivery and inventory issues and implement solutions.
• Lead corporate planning and execute long- and short-term business plans.
• Establish and monitor production control systems and budgets (OPEX/CAPEX).
• Collaborate with functions on new product development, marketing and support.
• Ensure compliance with safety, quality and regulatory standards.
• Recruit, develop and retain a high-performing operations team.
• Develop inventory control systems and manage supplier qualification and procurement.

Skills

GMP knowledge

FDA compliance

Regulatory knowledge

Lean manufacturing

Leadership

Budget management

Cost control

Problem solving

Strategic thinking

Stakeholder management

MRP/ERP systems

MS Office proficiency

Communication skills

Team building

Decision making

Education

Bachelor's degree in Pharmaceutical Sciences / Chemical Engineering / Business Admin

Tools

MS Office

ERP systems

Production management software

Job description

About the role

We are seeking an experienced Operation Director to join us in Simpang Ampat, Penang. This is a full-time position that plays a pivotal strategic role in overseeing and optimising all operational aspects of our pharmaceutical and medical devices manufacturing facility. The Operation Director will be responsible for driving operational excellence, ensuring regulatory compliance, and leading teams to deliver high-quality products that meet our customers' exacting standards. This role is integral to our mission of providing world-class contract development and manufacturing services to the global pharmaceutical industry.

Key responsibilities

• Manage and direct the operations department, set and monitor performance goals in line with Global operation strategy. Focus on continuous improvement of cost position, cycle time, product quality and overall efficiency.
• Develop and implement local operations processes and implement world-wide operations processes
• Negotiate Major purchasing contract, blanket orders, and long-term purchase agreements within the instructions and policies set by Company.
• Review production schedule to ensure the timely receipt and availability of materials.
• Analyze delivery and inventory issues and provide solution.
• Participate in corporate planning activities and implement long and short-term business plan set by the management.
• Establish and monitor the operation of production control system
• Collaborate with all functional groups in such matters as new product development, marketing, customer support and the like.
• Address physical safety issues and employee's safety attitude. Maintain and improve housekeeping in all areas.
• Responsible for the site operations budget, including OPEX and CAPEX.
• Within the instruction and policies set by the management, implement and maintain locally procurement policies which ensure the attainment of production goals, timely delivery of goods, equipment, material and supplies most economical cost, consistent with quality standard and specifications.
• Implement operating procedures concerning the selection and qualification of suppliers, processing of purchase requisition/order, control of price, quality requirements. Coordinates vendor search and selection
• Responsible locally for recruiting and developing a 'best-in the-industry' Operations team. Ensure development and implementation objectives attain output goals.
• Development and implementation inventory control systems to maintain and track the status of purchase order, inventory levels and production requirements.
• Direct the activities of assigned group through subordinate managers/supervisors. Determine organizational structure, manpower and material requirements.
• Establish and maintain production procedures and processes, in conformance with Tecan policies and applicable regulation and standards, such as FDA Quality System Regulation, ISO 13485, etc.
• Ensure that employees understand the impact of their job performance on quality and that quality policy is understood, implemented, and maintained in all operations function to ensure that devices are produced in accordance with the requirement of Tecan's Quality System and ISO 13485, etc.
• Duties and responsibilities include the principal functions of the job. The job description shall not be construed as a complete listing of all miscellaneous, incidental or other duties that may be assigned during normal operations.
• Miscellaneous, incidental or other duties that may be assigned during normal operations.

What we're looking for

• Bachelor's degree in a relevant field such as Pharmaceutical Sciences, Chemical Engineering, Business Administration, or a related discipline
• Minimum 10+ years of operations management experience in pharmaceutical manufacturing or medical devices industries
• Progressively increasing responsibility of operations management experience, scheduling, materials, manufacturing, and production control activities.
• Strong knowledge of GMP regulations, FDA compliance, and international regulatory frameworks
• In-depth knowledge of manufacturing processes, quality management systems, and regulatory standards (ISO 9001, ISO 13485, IATF 16949, FDA, ISO 14001).
• Demonstrated expertise in lean manufacturing, process optimisation, and continuous improvement methodologies
• Excellent leadership and people management skills with the ability to motivate and develop teams
• Strong financial acumen with proven experience in budget management and cost control
• Excellent problem-solving abilities and strategic thinking skills
• Outstanding communication and stakeholder management capabilities
• Proficiency in MRP/ERP systems, production management software, and Microsoft Office Suite.
• Excellent leadership, coaching, and team-building abilities.
• Strong communication skills (verbal and written) for effective interaction with all levels of the organization and external partners.
• Ability to manage conflict, resolve issues, and make sound decisions under pressure.
• Capable of driving improvement and change in the organization.
• Treats people with respect, keeps commitments, inspires the trust of others, work with integrity and ethics, and uphold organizational values.

About us

WE are leading contract development and manufacturing organization (CDMO) specializing in pharmaceutical and medical device manufacturing. We are part of a global network committed to delivering innovative, high-quality solutions to the pharmaceutical industry. Our facility in Penang is equipped with state-of-the-art technology and operates under the strictest regulatory standards. We pride ourselves on our commitment to excellence, innovation, and customer satisfaction. Our team is dedicated to supporting the development and commercialization of life-saving medications and medical devices that improve patient outcomes worldwide.

What we offer

We offer a competitive salary and comprehensive benefits package tailored to reward your expertise and contribution. Benefits include comprehensive health and medical insurance coverage, professional development and training opportunities, and a supportive workplace culture that values innovation and continuous improvement. We are committed to fostering a diverse and inclusive workplace where all employees can thrive. We provide career progression opportunities within a global organization and the chance to work on meaningful projects that impact the healthcare industry. We also offer flexible working arrangements where appropriate, and priorities the health and wellbeing of our employees through various wellness programmers and support services.