About the role
AI summarisedThe Director of Quality Assurance at Amgen Singapore Manufacturing will lead quality systems and compliance efforts to support the manufacturing of biologic therapies. This role involves overseeing quality operations, ensuring regulatory adherence, and driving continuous improvement in a fast-growing Asia Pacific biomanufacturing environment.
BiotechOnsiteQuality
Key Responsibilities
- Oversee Quality Assurance support for all ASM manufacturing activities (including on-the-floor quality oversight, batch record review, quality records approval), IS, PD, F&E, QC, Validation and Supply Chain GMP activities (including on-the-floor quality oversight, Incoming Quality, Data Integrity Assessments, Periodic Reviews, PLC, Delta V, Enterprise Systems) Supervise in New Product Introduction (NPI) team to ensure robustness of product changeover as well as cross contamination controls are in place.
- Oversee site inspection management, participate in regulatory inspections and interact directly with regulatory inspectors.
Requirements
- Doctorate degree in Chemistry, Chemical Engineering Science or related technological field and 4 years of directly related experience OR Master’s degree in Chemistry, Chemical Engineering Science or related technological field and 8 years of directly related experience OR Bachelor’s degree in Chemistry, Chemical Engineering Science or related technological field and/or 10 years of directly related experience Preferred 12+ years of relevant work experience in the commercial manufacturing environment within the pharmaceutical industry Experience with leading teams conducting batch record review, raw material and product release Experience in pharmaceutical equipment operation, design and control Experience in leading teams providing floor support, troubleshooting unit operations, and resolving and documenting investigations to support cGMP production Experience in leadership roles with facility commissioning and validation strategy development and execution Strong communication skills (technical writing and verbal communication/presentation) Work in and lead teams effectively with variety of communication and working styles Ability to independently conduct budget, workforce planning and staff management and development Demonstrated skills in the following areas: Lead and manage projects Commissioning and Qualification Scheduling and budget Collaboration Facility Licensing, Regulatory audits and inspections Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality Thrive What you can expect of us As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
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