Senior Regulatory & Quality Executive (MNC)

Location: Petaling Jaya, Selangor

Job Descriptions:

• Lead the establishment, implementation, maintenance, and continuous improvement of the Quality Management System (QMS) for Malaysia and Brunei operations, including distribution centres.
• Oversee key quality processes, including Change Control, Non-Conformance, CAPA, and Complaint Management, ensuring timely investigations, risk assessments, root cause analysis, and effective corrective and preventive actions.
• Ensure compliance with regulatory requirements and company quality standards for labeling, packaging, repack/relabel activities, controlled substances, and combination products.
• Provide quality support for product lifecycle activities, including new product launches, product discontinuations, product release, temperature excursions, field actions, and trade returns.
• Serve as the site Quality Subject Matter Expert for audit readiness and inspection management, supporting regulatory inspections and internal audits.
• Manage and maintain quality documentation systems.
• Lead Quality Management Review meetings and quality metrics reporting to drive continuous improvement.
• Oversee supplier and distributor qualification, monitoring, and compliance activities related to purchasing controls.
• Ensure distributor compliance with company quality standards and local regulations.
• Act as the regional SME for assigned quality systems across Southeast Asia and India, supporting regional quality projects, initiatives, and continuous improvement programs.

Job Requirements:

• Bachelor’s degree in Science, Engineering, Pharmacy, Data Science, or related field studied.
• At least 4–5 years of relevant experience in Regulatory and Quality Management, preferably within the pharmaceutical/Medical Device/Consumer Health industry.
• Proficiency in MS Office applications, SAP, and digital tools is required. Experience with Power BI, Power Automate, and Power Apps is highly desirable.
• Strong analytical and problem-solving skills with the ability to identify root causes and implement improvements.
• Able to work independently in a multinational environment and manage multiple priorities within tight deadlines.

Others Information:

For those who have what it takes, please send in resume to:

Recruitment Consultant : Janice Lim

Email : janice@brightprospect.com.my