Commercial Quality Lead, MSI

The Position

The Commercial Quality Lead, MSI plays a pivotal leadership role in ensuring the quality, safety, and regulatory compliance of Human Pharma and Animal Health products across Malaysia, Singapore, Indonesia.

This position oversees commercial quality strategy, budget, operations, supplier and partner quality oversight, and post‑marketing quality activities. You will lead the implementation of regulatory and internal quality requirements, collaborate closely with regional ASKAN teams, and represent Commercial Quality in key functional, regional, and global initiatives.

You will drive quality governance, support business continuity, enable timely product supply, and ensure that all products distributed in the MSI region meet the highest standards of quality and compliance.

Tasks and Responsibilities

• Manage the Commercial Quality (CQ) budget, team, and operations for the MSI (Malaysia, Singapore, Indonesia)


• Manage and perform MSI CQ operations and maintain the Quality Management System in accordance with applicable regulatory and internal requirements.


• Provide CQ input and support to MSI business teams to ensure continuous and timely supply of quality‑compliant products


• Oversee the quality management of suppliers (e.g., distributors, freight forwarders, graphic offices, repackaging component suppliers) and external business partners (e.g., Market Authorization Holders), including GDP/GMP audits and ensuring adherence to quality agreements


• Understand and implement applicable regulatory and internal requirements (e.g., regulations, guidelines, global/regional/local SOPs) across MSI Business Operating Units (BOPUs)


• Implement relevant global and regional Commercial Quality strategies within MSI BOPUs


• Conduct supplier quality audits and internal audits (self‑inspections) for BOPUs within the ASKAN region (Asia, South Korea, Australia, New Zealand) when required.


• Lead periodic Quality Management Reviews for MSI BOPUs and serve as the Local Product Compliance Officer for post‑marketing activities (e.g., product complaints, regulatory or market actions)


• Represent Commercial Quality in MSI business meetings (e.g., HPLC, AHLC, S&OP) and act as the interface between the ASKAN CQ Head and MSI business stakeholders to ensure timely and appropriate CQ support


• Serve as the ASKAN Local Management System Owner (MSO) or Deputy Local MSO for designated quality systems (e.g., CAPA Management)


• Support CQ operations or serve as backup for CQ Leads in other ASKAN BOPUs when required


• Present Commercial Quality topics and contribute to business, global, and regional projects and initiatives


• Perform any other tasks as assigned

About Our Future Employee

• Holds a Bachelor of Science degree in Chemistry, Pharmacy, Chemical Engineering, or a related scientific field; a relevant science diploma with strong experience is also acceptable


• Has 7–10 years of Quality experience in a pharmaceutical, biologics, or medical device multinational company; GMP experience is an advantage.


• Has at least 5 years of experience managing and executing commercial quality operations at a country level; experience overseeing multiple countries is a plus.


• Possesses thorough knowledge of GDP regulatory requirements and practical expertise in commercial quality operations within pharmaceuticals, vaccines, or medical devices


• Works effectively both independently and in a collaborative, team‑oriented environment


• Demonstrates strong attention to detail, organizational abilities, and flexibility


• Shows a strong sense of urgency, efficiency, and the ability to manage multiple priorities


• Has excellent oral and written communication skills in English


• Communicates results and project status clearly to stakeholders at all levels


• Prepares high‑quality technical reports, executive summaries, and management presentations


• Demonstrates strong analytical capability, including the ability to identify information needs, interpret data, and draw sound conclusions


• Exercises mature judgment and strong decision‑making skills in addressing product and project issues


• Is able to work effectively with complexity and think critically