Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

MANAGER QUALITY ASSURANCE

LIVE

What you will do

In this vital role you will ensure Amgen’s distribution activities for our commercial product portfolio are compliant with EU Good Distribution Practice (GDP) and local regulations by acting as the primary Responsible Person for Ireland and the main point of contact for the Healthcare Products Regulatory Agency (HPRA).  You will also ensure compliance with the EU Medical Device Regulations (MDR), In Vitro Diagnostic Regulations (IVDR) and Amgen’s Quality Management System (QMS).  Additionally you will support the UK Quality operations as required.  Your key responsibilities will include:  

• As Responsible Person, ensuring distribution activities and the QMS are compliant with local wholesaling guidance, EU GDP guidelines, the EU MDR and IVDR, including handling all quality matters relating to Product Complaints and Recalls
• Hosting regulatory inspections and participating in internal audits and self-assessments
• Collaborating closely with Amgen’s distribution and manufacturing functions and the UK & Ireland Affiliate (Leadership, Regulatory, Medical, Commercial, Safety) to ensure Quality Standards are met
• Providing Quality oversight of third party outsourced activities including due diligence audits, and implementing and maintaining Quality Agreements
• Providing Quality Assurance review and approval of GDP-related records, including deviations, temperature excursions, CAPAs and Change Controls. Undertaking ownership of other QMS documents, e.g. Standard Operating Procedures (SOPs)
• Supporting new product launches

Be part of our team

You would be joining Amgen’s International Distribution and Quality (IDQ) organisation as part of the UK/Ireland Affiliate team of experienced Quality professionals.  IDQ has responsibility for ensuring regulatory compliance with all aspects of Amgen’s product distribution outside of the USA.

WIN

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced  professional, are these qualifications and skills:

• Be eligible to act as a Responsible Person in Ireland
• Degree in Pharmacy or relevant Life Sciences subject, or equivalent relevant experience
• Demonstrable experience of working with Pharmaceutical Industry, particularly in Distribution and/ or Manufacturing Quality

• Strong understanding of EU and local Regulatory Quality requirements (GDP and GMP) and pharmaceutical quality systems
• Demonstrated ability to navigate through ambiguity and to provide a structured problem-solving approach, including capability to work on multiple projects within a deadline-driven environment
• Strong communication, problem solving and investigation skills
• Working knowledge of MS Office tools and relevant pharmaceutical computerized systems

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

LOCATION: Flexibility of home working with occasional work from our Dublin office.

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.