Impress employers and recruiters.
Choose from hundreds of resume examples.

Impress employers and recruiters.
Choose from hundreds of resume examples.

Target Resume Now

About the Role

Help shape the future of quality at Amgen, a leading biotechnology company committed to delivering innovative and life-changing therapies. This role provides quality oversight for internal Amgen Quality Records and external Contract Manufacturing locations in Japan, operating at the intersection of quality, innovation, and global collaboration to ensure reliable product supply.

Responsibilities

• Review and approve quality documentation, including master batch records, deviations, CAPAs, product complaints, and change controls.
• Perform tactical batch disposition activities in support of lot release.
• Negotiate Quality Agreement terms and conditions and ensure adherence.
• Act as a key quality partner to manufacturing, supply chain, process development, and other Amgen internal functions.
• Lead cross-functional initiatives and continuous improvement projects to improve regional operations.
• Ensure inspection readiness for contract manufacturing sites and internal Amgen records.
• Support management of audit/inspection commitments to completion.
• Represent Amgen at product-specific regulatory inspections of the contract manufacturing site.
• Lead supplier audits for suppliers located in the JAPAC region.
• Perform person in plant responsibilities during Amgen manufacturing campaigns or to support key process steps at the contract manufacturer.
• Provide quality oversight of new product introductions, tech transfers, and process qualification activities at the contract manufacturing site.
• Drive proactive quality management of suppliers, ensuring compliance with global GMP standards and Amgen’s high expectations.

Requirements

• Bachelor or Master’s degree.
• At least 6 years of Quality and Compliance experience.
• Strong background in GMP compliance, ideally with a focus in manufacturing or materials management.
• Quality and/or Manufacturing experience at small and/or large molecule drug substance, drug product, and packaging manufacturing facilities.
• Proven ability to lead audits, manage complex investigations, and influence quality improvements.
• Skilled in using risk based decision-making approaches.
• Experience with regulatory activities, variation management, and commercial product disposition requirements in Japan.
• Experience with analytical testing situations (e.g. method transfers, analytical qualifications, stability, lab investigations, in process testing, release testing).
• Track record of driving change, improving systems, and mentoring others within Quality.

Skills

• Excellent English and Japanese communication skills – both written and oral.
• Confident communicator who can build relationships across technical and cultural boundaries.

Location

• JAPAC region

Work Type

• Occasional travel
• Onsite engagement

Experience Level

• 6 years of Quality and Compliance experience

Education Level

• Bachelor or Master’s degree

Benefits

• Comprehensive Total Rewards package

About the Company

• Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
• This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
• Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives.
• A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
• Our award-winning culture is collaborative, innovative, and science based.