Kuala Lumpur, MYS
3 days ago
Senior Specialist Commercial Quality, MSI
**The Position** As a Senior Specialist in Commercial Quality, you will play a key role in safeguarding the quality and regulatory compliance of Human Pharma and Animal Health products across the MSI (Malaysia, Singapore, Indonesia).You’ll be at the responsible of ensuring our products remain safe, effective, and compliant - supporting commercial quality operations, managing supplier and partner quality, driving post‑marketing quality activities, and implementing both regulatory and internal quality requirements. This role gives you the opportunity to collaborate across functions and regions, contribute to meaningful business and quality initiatives, and make an impact throughout the entire product lifecycle. **Tasks and Responsibilities** + Perform MSI Commercial Quality (CQ) operations and maintain the Quality Management System in accordance with applicable regulatory and internal requirements + Support the management of MSI CQ operations as needed. + Provide CQ input and support to MSI business teams to ensure continuous and timely supply of quality‑compliant products + Support 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 conducting GDP/GMP audits and ensuring adherence to quality agreements + Understand and support the implementation of applicable regulatory and internal requirements (e.g., regulations, guidelines, global/regional/local SOPs) across MSI Business Operating Units (BOPUs) + Support the implementation of relevant global and regional CQ strategies within MSI BOPUs + Perform supplier quality audits and internal audits (self-inspections) for BOPUs across ASKAN (Asia, South Korea, Australia, New Zealand) when required + Support or conduct periodic Quality Management Reviews for MSI BOPUs and assume the Local Product Compliance Officer (or Deputy) role for post‑marketing activities (e.g., product complaints, regulatory/market actions) + Represent the MSI CQ Lead in periodic and ad hoc business meetings (e.g., HPLC, AHLC, S&OP) when required. Act as the interface between the ASKAN CQ Head and MSI business partners, both internal and external, to ensure timely and appropriate CQ support + Assume the ASKAN Local Management System Owner (MSO) or Deputy Local MSO role for designated quality systems (e.g., CAPA Management) + Support CQ operations and activities in other ASKAN BOPUs when needed + Present ASKAN CQ topics and provide input and support for 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, or a relevant science diploma with applicable work experience + Has 3-5 years of Quality experience in a pharmaceutical, biologics, or medical device multinational company; + Has at least 3 years of experience in managing and executing country commercial quality activities in a pharmaceutical, biologics, or medical device multinational company; experience covering multiple countries is a plus + Possesses strong knowledge of GDP regulatory requirements and practical expertise in commercial quality operations within the pharmaceutical, vaccines, or medical devices industry + Works effectively both independently and in a team‑oriented environment. + Demonstrates strong attention to detail, organizational skills, and flexibility. + Exhibits a strong sense of urgency and efficiency + Manages multiple activities simultaneously + Has excellent oral and written communication skills in English. + Communicates results and project status clearly to internal and external stakeholders + Prepares technical reports, executive summaries, and management presentations effectively + Demonstrates strong analytical and critical‑thinking skills, including the ability to determine information needs, identify appropriate sources, and draw sound conclusions + Exercises mature judgment and strong decision‑making skills in addressing project and product issues + Able to work through complexity and think critically All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
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