Executive, R&D Quality Management

Location: Glenmarie, Selangor

Company: Duopharma Innovation Sdn Bhd

Job Summary

This role supports new product development activities through the management of Active Pharmaceutical Ingredients (API), supplier coordination, regulatory documentation, and quality compliance initiatives. You will work closely with internal stakeholders, API manufacturers, and regulatory authorities to ensure materials and documentation meet development, quality, and registration requirements.

Key Responsibilities

API Management & Product Development

• Support new product development projects through effective management of APIs and related documentation
• Conduct literature reviews and technical research to support product development initiatives
• Source and evaluate new APIs and materials required for development projects
• Ensure APIs and materials meet technical, quality, and regulatory requirements

Regulatory Documentation & Product Registration

• Prepare API-related documentation for Common Technical Document (CTD) submissions
• Coordinate communications between API suppliers and the National Pharmaceutical Regulatory Agency (NPRA)
• Ensure Drug Master Files (DMFs) and Letters of Access are available to support development and product registration activities
• Maintain accurate API documentation and regulatory records

Supplier & Vendor Management

• Develop and maintain strong relationships with API manufacturers and service providers
• Ensure confidentiality agreements and non-disclosure agreements are established with vendors and contract organizations
• Evaluate supplier capabilities, qualifications, delivery performance, and compliance status
• Support supplier management and vendor qualification activities

Quality Compliance & Risk Management

• Support quality initiatives including vendor evaluation, New Source Evaluation (NSE), supplier qualification, and internal audits
• Participate in Nitrosamine Risk Assessments and Elemental Impurity Risk Assessments
• Ensure compliance with applicable quality standards including GMP, ISO 17025, ISO 13485, and ISO 37001 requirements
• Support HALAL compliance assessments for new materials

Procurement & Project Coordination

• Assist in procurement planning and material purchasing activities in accordance with company procedures
• Support cost evaluations and negotiations for R&D and commercial materials in collaboration with Purchasing
• Maintain product pipeline information and prepare pipeline status reports when required
• Participate in continuous improvement, operational excellence, and Kaizen initiatives

Requirements

Qualifications

• Bachelor's Degree (Hons.) in Chemistry or related scientific discipline

Experience

• Minimum 1–2 years of experience in the pharmaceutical industry
• Exposure to API management, regulatory affairs, supplier management, or product development activities is an advantage

Technical Skills & Knowledge

• Knowledge of pharmaceutical regulatory requirements and product registration processes
• Understanding of Drug Master Files (DMF) and Common Technical Documents (CTD)
• Familiarity with supplier qualification and vendor management processes
• Project management and coordination skills
• Strong computer literacy and documentation management skills

Competencies

• Strong communication and stakeholder management skills
• Good negotiation and influencing abilities
• Strong attention to detail and compliance mindset
• Effective teamwork and collaboration skills
• Ability to manage multiple projects and deadlines simultaneously