Senior R&D Quality & Lab Operations Manager

Duopharma Biotech Bhd Group of Companies.; Shah Alam; On-site; MYR 180,000 - 240,000; Full time

Job summary

Duopharma Innovation Sdn Bhd in Glenmarie, Selangor seeks an experienced Assistant Manager/Senior Executive to lead the R&D Quality Management team. You will oversee analytical laboratory activities, support pilot batches and process validation, and ensure GMP/GLP compliance.

You will coordinate method transfer and technology transfer, review protocols and reports for regulatory submissions, and drive continuous improvement in laboratory quality and efficiency.

Qualifications

• Bachelor's degree in biotechnology, pharmaceutical science, chemistry, or related field.
• Minimum 5 years in pharma quality/R&D for Senior Executive; 10 years for Assistant Manager.
• Experience leading analytical lab operations and regulatory compliance (GMP/GLP/ISO).

Responsibilities

• Manage daily analytical laboratory activities and personnel.
• Support regulatory submissions with R&D quality data.
• Ensure GMP, GLP, ISO 9001, ISO 13485, ISO/IEC 17025 compliance.
• Coordinate method transfer and technology transfer during scale-up.
• Review protocols, test reports, and stability studies.
• Lead continuous improvement in laboratory quality and efficiency.

Skills

Regulatory knowledge

Leadership

Project management

Quality assurance

Communication

Education

Bachelor's degree in Biotechnology, Pharmaceutical Science, Chemistry, Analytical Science, or related discipline

Tools

Analytical instruments

Quality management systems

Job description

Duopharma Innovation Sdn Bhd in Glenmarie, Selangor seeks an experienced Assistant Manager/Senior Executive to lead the R&D Quality Management team. You will oversee analytical laboratory activities, support pilot batches and process validation, and ensure GMP/GLP compliance.

You will coordinate method transfer and technology transfer, review protocols and reports for regulatory submissions, and drive continuous improvement in laboratory quality and efficiency.