Regional Pharma Quality Compliance Leader

Manpower Staffing Services (Singapore) Pte Ltd; Singapore; On-site; SGD 80,000 - 134,000; Full time

Job summary

CSL Behring seeks a Pharma Quality Compliance Manager to serve as the Regional Quality Officer for the Asia South and Singapore/Malaysia Affiliate Operations. The role ensures compliance with the Quality System, supports product complaints, investigations and recalls, and collaborates across Commercial Operations, Logistics and manufacturing sites.

The successful candidate will manage QA activities, maintain quality agreements, oversee deviations, CAPAs, and drive GxP training and readiness

Qualifications

• Bachelor’s degree in a relevant business or science discipline.
• Minimum 5 years’ GMP quality or systems experience in pharmaceutical manufacturing, drug products or related field.
• Experience with Good Distribution Practices (GDP) systems implementation is desirable.
• Strong communication, collaboration and negotiation skills.
• Limited travel may be required.

Responsibilities

• Supports investigation and reporting of product complaints per global procedures and ensures CAPAs are implemented.
• Acts as main QA oversight for Asia South & Singapore distributors and supports logistics deviation investigations.
• Oversees final administrative release for products and liaises with manufacturing site Qualified Persons.
• Collaborates with Customer Service, Medical Information and Global Logistics to resolve inquiries post-release.
• Acts as Affiliate Recall Coordinator for recalls and market actions.
• Maintains Quality Agreements between Asia South & Singapore distributors and Sites of Manufacture.
• Establishes and maintains a GxP training program for Asia South & Singapore.
• Manages Quality Management System documentation including Policies, SOPs and Work Instructions.
• Prepares documentation for global inspections and maintains inspection readiness.

Job description

CSL Behring seeks a Pharma Quality Compliance Manager to serve as the Regional Quality Officer for the Asia South and Singapore/Malaysia Affiliate Operations. The role ensures compliance with the Quality System, supports product complaints, investigations and recalls, and collaborates across Commercial Operations, Logistics and manufacturing sites.

The successful candidate will manage QA activities, maintain quality agreements, oversee deviations, CAPAs, and drive GxP training and readiness