Quality Compliance Senior Manager - Labelling & Regulatory Affairs

What you will do

In this vital role you will strengthen and advance Amgen's R&D Quality Management System (QMS) and Safety & Medical Quality (SMQ) competencies. This role will lead Safety and Medical Quality processes with a focus on labelling and regulatory affairs activities. This role will be responsible for leading processes and activities related to the pharmacovigilance (GPvP) annual audit plan, the preparation and execution of audits, the investigation and monitoring of Quality events and supporting partner audits and regulatory inspections. The Quality Lead role in the Safety & Medical Quality organization will lead proactive identification of compliance issues relating to processes and programs, and escalation to compliance and quality oversight bodies, and participate in quality investigations, management, and remediation.

• Act as the Quality Lead contact for Labelling & Regulatory Affairs activities within R&D Quality.
• Ensure proactive identification of issues relating to processes, programs, and external relationships, elevate issues to appropriate compliance/quality oversight bodies and participate in compliance investigations, management, and remediation.
• Assess and manage risks including providing input into the development of the annual GPvP audit plan.
• Participate as the Quality representative for evaluating and providing oversight of Labelling and Regulatory Affairs vendors/service providers.
• Prepare, analyze, and communicate compliance metrics (e.g., deviation, audit and inspection data) and other significant compliance information.
• Represent R&D Quality during governance and management review meetings that involve Labelling and Regulatory Affairs.
• Maintain knowledge of current regulatory and compliance practices/issues, assess changes in regulations and the external environment, and advise customers.
• Support inspections and external audits, including preparing, conducting, and closing out response reviews.
• Provide support for audit planning meetings, debriefs, audit plan outlines and response reviews.
• Develop long-term remediations and process improvements through Root Cause Analysis (RCA). Improve R&D processes by contributing expertise in identifying robust Corrective and Preventive Action plans (CAPA) and Effectiveness Verifications.
• Actively seek and implement innovative and proactive quality oversight methodologies.

What we expect of you

• Degree educated
• Experience in Quality Management, Quality Compliance or other relevant risk based quality practices in the pharmaceutical/biotech industry and thorough knowledge of R&D processes and operations
• Thorough knowledge and application of international requirements of Good Pharmacovigilance Practice (GPvP) & Regulatory Affairs
• Previous experience supporting regulatory authority inspections of pharmacovigilance activities
• Experience of leading and/or supporting process improvement initiatives
• Previous leadership or mentoring experience is ideal

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 occasional office work from our Cambridge or Uxbridge next generation workspaces.

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.