Director Quality Assurance

Director Quality Assurance

Amgen Singapore Manufacturing, Singapore

HOW MIGHT YOU DEFY IMAGINATION?

Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a Director, Quality Assurance in Amgen Singapore Manufacturing.

Live

What you will do

Main Responsibilities:

• Quality Professional with extensive background and experience in commercial production of Biologics and traditional GMP active pharmaceutical ingredient (API) drug substances.
• Provide Quality leadership and oversight to plant operations, ensuring appropriate application and execution of GMP compliance requirements and Amgen Quality Management System through phases of facility design, commissioning, process qualification, regulatory approval and market supply to establish a Quality culture for routine operations.
• 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.
• Act as delegate to Quality Assurance Executive Director when required to support business needs.

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

• 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

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Please contact us to request an accommodation.