Assistant Manager/Senior Executive, R&D Quality Management

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

Assistant Manager/Senior Executive, R&D Quality Management

Location: Glenmarie, Selangor
Company: Duopharma Innovation Sdn Bhd

Job Summary

We are seeking an experienced and technically competent Assistant Manager to support our R&D Quality Management team. This role is responsible for managing analytical laboratory activities, supporting pilot batches and process validation projects, overseeing analysts, and ensuring laboratory operations comply with applicable GMP, GLP, ISO 9001, ISO 13485, and ISO/IEC 17025 requirements.

The successful candidate will play a key role in analytical testing, method transfer, technology transfer, stability studies, qualification activities, and the review of quality and technical documentation supporting pharmaceutical product development and regulatory submissions.

Key Responsibilities

Laboratory & R&D Quality Management

Manage and coordinate daily analytical laboratory activities, projects, and personnel.

Support R&D Quality Management activities and analytical requirements for regulatory submissions.

Ensure laboratory operations comply with GMP Annex 13, Good Laboratory Practice (GLP), ISO 9001, ISO 13485, and applicable ISO/IEC 17025 practices.

Assist in planning, organising, controlling, and directing R&D and laboratory activities.

Analytical Testing & Validation

Manage and support analytical testing for pilot batches, process validation, stability studies, and product development projects.

Support IQ, OQ, and other equipment qualification activities, including temperature mapping.

Ensure all testing activities are conducted in accordance with approved Protocols of Analysis (POA) and relevant procedures.

Initiate troubleshooting and problem-solving activities to address technical issues and improve laboratory performance.

Analytical Method & Technology Transfer

Support Analytical Method Transfer (AMT) and technology transfer activities during product scale-up and commercialisation.

Coordinate method transfer to receiving or commercial technical teams.

Provide technical analytical information, troubleshoot issues, and advise on appropriate precautions during analytical activities.

Support cross-functional teams in ensuring successful product and method transfer.

Documentation & Quality Compliance

Prepare, review, and approve Quality Management and technical documentation.

Review documentation related to pilot batches, process validation, analytical method transfer, and technology transfer activities.

Review protocols and reports, including stability studies, Comparative Dissolution Profile (CDP), temperature mapping, pilot batches, and process validation.

Review and approve documents such as IQ, OQ, PQ, URS, Certificates of Analysis (CoA), and Stability Summary Reports (SSR).

Ensure documentation complies with applicable GMP, ICH, ASEAN, and other relevant regulatory guidelines.

Laboratory Management

Support the management and maintenance of laboratory equipment.

Manage laboratory inventory, chemicals, consumables, and operating supplies.

Ensure laboratory cleanliness, organisation, and readiness for daily operations.

Support continuous improvement initiatives to enhance laboratory efficiency, quality, and compliance.

Requirements

Qualifications

Bachelor's Degree in Biotechnology, Pharmaceutical Science, Chemistry, Analytical Science, or a related scientific discipline.

Minimum 5 years of working experience for Senior Executive & 10 years of working experience for Assistant Manager

Experience

Significant working experience in the pharmaceutical or related regulated industry.

Experience in analytical laboratory operations, pharmaceutical R&D, Quality Management, or analytical testing is preferred.

Experience managing laboratory personnel and projects will be an added advantage.

Technical Skills & Knowledge

Good knowledge of pharmaceutical regulatory requirements and guidelines, including NPRA, FDA, ICH, ASEAN, EMEA, GLP, and WHO requirements.

Knowledge of formulation support studies, pilot batch studies, process validation, and analytical method validation.

Strong project management and technical problem-solving skills.

Experience reviewing and preparing technical protocols and reports.

Hands‑on experience with analytical instruments will be an added advantage.

Strong analytical and research capabilities.

Excellent troubleshooting and problem-solving skills.

Strong leadership and team management abilities.

Good project planning and organisational skills.

Ability to communicate effectively with employees at all levels.

Strong attention to detail and commitment to quality and compliance.

Ability to motivate and lead a team in a highly regulated environment.

Pharmaceuticals, Biotechnology & Medical Devices 101-1,000 employees

Duopharma Biotech Berhad began with the establishment of Duopharma (M) Sdn Bhd in 1978. Incorporated in 2000, we are one of Malaysia’s leading pharmaceutical companies listed on the Bursa Malaysia’s Main Market. We specialise in manufacturing, R&D, and marketing of generic drugs and consumer healthcare products (CHAMPS®, FLAVETTES® & UPHAMOL) as well as biosimilars (ERYSAA®, Basalog One®). As a pioneer in halal pharmaceuticals, we were the 1st to receive JAKIM certification for OTC and prescription products under MS2424:2019. Headquartered in Kuala Lumpur, we operate three GMP-certified plants (Klang, Bangi & Glenmarie) and have a growing presence in Indonesia, the Philippines and Singapore.