Head of International & Distribution Quality Taiwan

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 Head of International & Distribution Quality in Taipei, Taiwan.

Head of International & Distribution Quality Taiwan

Live

What you will do

Main Responsibilities:

• To have oversight and ensure compliance of all systems that impact on the quality of product manufactured, distributed or stored within Taiwan.
• Ensuring that a quality management system is implemented and maintained.
• Focusing on the management of authorise d activities and the accuracy and quality of records.
• Ensuring that initial and continuous training programs are implemented and maintained.
• Coordinating and promptly performing any recall operations for medicinal products.
• Ensuring that relevant customer complaints are dealt with effectively.
• Ensuring that suppliers and customers are approved.
• Approving any subcontracted activities which may impact on the regulations.
• Ensuring that self inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.
• Keeping appropriate records of any delegated duties.
• Deciding on the final disposition of returned, rejected, recalled or falsified products.
• Approving any returns to saleable stock. (Not applicable to Taiwan market)
• Other distribution activities.
• Ensuring that any additional requirements imposed on certain medicinal products by national legislation are adhered to.
• Ensure compliance to overall PIC/S GMP and PIC/S GDP distribution activities and compliance /execution to Amgen Quality Management System.
• Responsible for ensuring any local legislation changes that impact G x P operations are communicated and systems or procedures are updated accordingly.
• Provide direct support for G x P Inspections by authorizes that impact Amgen sites and 3rd parties
• Manage all communication with Regulatory Authorities in Taiwan on G x P matters
• Approval and Quality oversight of Contract Laboratories, Distributors and Logistic Service Providers in Taiwan.
• Ensure appropriate oversight of shipment and distribution of Commercial Product to ensure product quality
• Implementation and ongoing management of Quality Systems at Amgen - Amgen Taiwan to include Information Systems, G x P Procedures and Policies and Training Curriculum, as per G x P regulations in Taiwan as well as Amgen policies
• Assess Taiwan regulations, standards and guidance documents related to GxP, product testing and Taiwan Pharmacopoeia requirements; represent Amgen in key industry groups in Taiwan and provide Amgen stakeholders with guidance and interpretation on these requirements.
• Alerts senior management and authority of significant quality, compliance, supply and safety risks

Note:  Other responsibilities, accountabilities or decision authorities may be assigned as a member of JAPAC Quality.

Win

What we expect of you

Qualifications

• Doctorate +4, Masters +8, Bachelors +10 years of directly related experience in quality assurance and quality related activities in a global commercial operation.
• Demonstrated ability to effectively manage a partnership alliance, including relationship development and maintenance, negotiation skills and oversight to monitor health of partnership
• Knowledge of quality requirements and local GxP requirements
• Experience performing GMP/GDP and GLP oversight of laboratories and manufacturers that perform analytical testing of biologics, LSPs and packaging suppliers.
• Pharmaceutical/ Biologics product commercialization and lifecycle management experience
• Native level in Chinese and English

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.

• 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

Apply now

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.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.