Quality Assurance (QA) Manager

Quality Assurance Manager

Kuala Lumpur, Malaysia / Singapore

HOW MIGHT YOU DEFY IMAGINATION?

Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a QA Manager in Malaysia.

Live

What will you do

As part of Amgen’s continued commitment to ensuring access to healthcare and growth within the region, our Malaysian entity was opened in 2023, and we are seeking a full-time, qualified QA Manager to support the day-to-day operations in line with the wider SEA markets. This individual will play a key role in the establishment of the entity in Malaysia and the continued growth and business performance.

The Manager of Quality Assurance at Amgen oversees the daily operations of the quality assurance team, ensuring that the company's products meet established quality standards. They implement and manage QA systems, coordinate audits, and lead initiatives to address and prevent quality issues.

Main Responsibilities:

• Support to hold relevant licenses for import/distribution of Amgen products in Malaysia.
• Maintain and implement an effective Quality Management System that meets local Health Authority's requirements.
• Management of wholesale and distribution activities of Amgen products in Malaysia.
• Review and approving Quality records.
• Ensuring that initial and continuous training programs are implemented and maintained.
• Ensuring that customer complaints are dealt effectively according to Standard Operating Procedures. 
• Ensuring that suppliers and customers are legally approved or authorized to enable lawful supply of products.
• Approving subcontract activities that may impact on Good Distribution Practice.
• Keeping appropriate records of any delegated duties.
• Deciding on the final product disposition.
• Leads and participates in internal and external audit as needed.
• Supports regulatory inspections or queries from Regulatory bodies.
• Contactable by Authority by way of mobile phone number or an electronic mail address

Win

What we expect of you

Qualifications

• Pharmacist Registration in Malaysia.
• Hold a valid practicing certificate as Pharmacist in Malaysia.
• In-depth knowledge and experience on Good Distribution Practice (GDP).
• Experience with Quality Management Systems including but not limited to change control, deviation, validation, complaints, disposition and audits/inspections.
• Experience with Commercial Quality Operations and third-party management.
• Experience with distribution models and/or establishment of new entity procedures a plus

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we work to care for our teammates’ professional and personal growth and well-being.

• 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