Amgen Quality & Compliance Auditor, Compliance Manager / R&D Auditor in Cambridge, United Kingdom

Quality & Compliance Auditor, Compliance Manager / R&D Auditor

The company:

Amgen is one of the world's largest independent biotechnology companies, with global revenue of $23 billion and nearly 20,000 employees globally. For more than 35 years, 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.

The Team:

R&D Audit are a global team that conduct audits internationally covering business processes, Amgen affiliates, marketing partners, Investigator sites, vendors, labs and CROs. They are responsible for all R&D auditing activities for GVP, GCP and GLP at Amgen.

The Role:

The successful candidate will be accountable for the execution of audits in the Quality, Compliance and Audit (QCA) program including the preparation, planning, scheduling, conduct and reporting of audits. Review and approval of audit responses to audits (predominantly in the PV space i.e. affiliate, PV marketing partners, Commercial distributors and PV related internal process audits). The role requires extensive international travel throughout the world (up to 40%).

Responsibilities

  • Plan, conduct and report routine audits with proficiency

  • Execute assigned audits in compliance with R&D audit timelines, SOPs and standards, in addition to local regulations and laws

  • Support complex audit types

  • Review, negotiate and approve responses to audit findings

  • Identify and communicate audit findings to QCA management

  • Support regulatory agency inspections

  • Support site inspection preparation visits at investigator sites

  • Contribute to the development of R&D Audit processes and controlled documents pertaining to the Audit function

  • Maintain knowledge of current regulatory and subject matter areas of expertise (e.g. GCP, PV)

  • Collaborate with other Amgen Compliance/Quality/Audit functions while conducting audits and/or during regulatory agency inspection activities

Basic Qualifications

  • Bachelor of Science degree in appropriate discipline or equivalent is required

Proven experience within

  • Proven experience from biopharmaceutical industry

  • Proven experience as an auditor in Good Pharmacovigilance Practice (GPvP). GCP experience would also be advantageous

  • Knowledge and application of international requirements of Good Pharmacovigilance Practice (GPV) (required) Good Clinical Practice (GCP)

  • Proven knowledge of R&D processes and operations

  • Excellent communication and presentation skills

  • Excellent relationship building skills across different organization levels

Location: Cambridge or Uxbridge

Remuneration: Competitive salary & comprehensive benefits package including bonus scheme

Amgen is an equal opportunities empoyer