Senior Manager QualityResponsible Person (Import)

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION

If you feel like youre part of something bigger its because you are. At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching manufacturing and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

SENIOR MANAGER QUALITY/RESPONSIBLE PERSON (IMPORT)

LIVE

What you will do

In this vital role you will ensure compliance with Good Distribution Practices (GDP) for the storage transport and distribution of medicinal products across the UK and Ireland. You will lead the regional Quality team maintain a robust Quality Management System (QMS) provide regulatory oversight partnering with internal and external stakeholders to ensure product quality compliance and continuous improvement.

Key Responsibilities:

• Lead the UK & Ireland Quality team and act as Responsible Person for Amgen Ltd.
• Ensure compliance with current GDP and applicable regulatory requirements for product distribution and importation.
• Maintain and oversee the QMS including deviations CAPAs change controls and effectiveness verification.
• Review and approve GDP-related procedures records and documentation.
• Support audits and inspections; ensure inspection readiness and regulatory commitments are met.
• Drive continuous improvement initiatives across Quality and/or Supply Chain.
• Assess and manage quality risks escalating significant issues to senior management.
• Ensure staff training and qualification in line with current GDP requirements.
• Serve as Regional Process Owner for QMS and represent Quality on cross-functional teams to resolve regional quality issues.

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:

• Degree educated.
• Eligible to act as Responsible Person / Responsible Person (import) (RP/RPi) in the UK meeting all MHRA eligibility criteria.
• Previous relevant experience performing RP duties under a Wholesale Dealers (Human) Authorisation (WDA(H)) or equivalent quality/QA experience within a pharmaceutical organization.
• Strong knowledge of UK and EU regulatory frameworks including: MHRA and EMA roles GDP UK Wholesale Distribution and Import regulations and the EU Pharmaceutical Directive.
• Membership of a UK professional body is mandatory.
• Demonstrated ability to make timely compliant risk-based decisions with high attention to detail.
• Proven experience managing small teams and working collaboratively across functions and seniority levels.
• Excellent analytical problem-solving communication and presentation skills
• Proficient in Microsoft Office ERP systems quality management systems and information and communication technologies.

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: Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace.

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.

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.