Quality Assurance Manager

Career Category

Job Description

Help shape the future of quality at Amgen.

At Amgen every step we take is driven by a powerful missionto serve patients. As one of the worlds leading biotechnology companies we are committed to delivering innovative and life-changing therapies to millions worldwide. Join our passionate team and play a pivotal role in maintaining the highest standards of quality while enabling global access to critical medicines.

Quality Assurance Manager (External Supply)

Live
What you will do
Are you a strategic quality leader ready to take on a high-impact role In this position youll be responsible for quality oversight for Internal Amgen Quality Records and external Amgen Contract Manufacturing locations in Japan. You will have regional responsibilities across manufacturing sites and operate at the intersection of quality innovation and global collaboration to ensure reliable and quality supply of our products. This role will require the candidate to be regionally based in the JAPAC region with strong technical communication skills required in both Japanese and English.

In this influential role you will:

• Review and approve quality documentation including master batch records deviations CAPAs product complaints and change controls with a sharp eye for risk and compliance.
• 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 and build meaningful and trusting team relationships.
• Take the lead in cross-functional initiatives and continuous improvement projects to improve regional operations and daily tasks.
• Ensure inspection readiness for our 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 on behalf of Amgen for suppliers located in the JAPAC region.
• As needed 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 Amgens high expectations.
• Role may require occasional travel and onsite engagement with contract manufacturing sites.

Win
What we expect of you
We are looking for a quality professional who thrives in a dynamic matrixed environment and is passionate about driving performance and fostering collaboration.

• Bachelor or Masters degree and at least 6 years of Quality and Compliance experience.
• Strong background in GMP compliance ideally with a focus in manufacturing or materials management.
• Excellent English and Japanese communication skills both written and oral.
• Confident communicator who can build relationships across technical and cultural boundaries.
• 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.

Thrive
What you can expect from us
At Amgen your growth is our priority. Join a quality organization where your expertise will be valued your voice heard and your career supported every step of the way.

• Continuous learning through global exposure and challenging projects.
• A supportive and inclusive culture where quality is everyones responsibility.
• Comprehensive Total Rewards package
• Opportunities for international collaboration

As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture well support your journey every step of the way.

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. As a member of the Amgen team youll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives.

Our award-winning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.