Senior Manager Quality/Responsible Person (Import)Cambridge, GBRPosted today

Senior Manager Quality/Responsible Person (Import)

Location: Cambridge, United Kingdom

Posted today

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, and partner 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.

What We Expect Of You

• 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 Dealer\’s (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.

What You Can Expect Of Us

• 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 Cambridge or Uxbridge next generation workspace.

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.