R&D Quality Senior Manager

R&D Quality Senior Manager

Amgen

Lisbon, Portugal

What you will do

Let’s do this! Let’s change the world! In this vital role the R&D Quality Senior Manager will play a crucial part in ensuring global compliance with regulatory standards by preparing and coordinating cross-functional teams for Regulatory Health Authority inspections. Responsibilities include developing and executing inspection management plans, managing and enhancing the R&D inspection framework, ensuring appropriate resourcing and time zone alignment, and supporting Regulatory Inspection Intelligence processes while contributing to operational quality initiatives. As part of the diverse, international Clinical Quality Inspection team within the Global R&D Quality organization, this individual will help strengthen the R&D Quality Inspection Management System, provide oversight of R&D processes, and lead activities related to GCP regulatory inspections.

Responsibilities

• Ensures, that because of inspection preparation activities, story boards are being developed for key processes and activities. Organizes presentations of the story boards and mock interviews in preparation of potential Sponsor inspections.
• Ensures that a cross-functional team (e.g. Quality, Clinical Operations, other functional areas, PV/GPS, GRAAS, DTI, etc.) is fully informed and prepared to support any Regulatory Health Authority inspection, worldwide.
• Acts as the subject matter expert and primary point of contact for relevant functional areas on Inspection Management to provide real-time, proactive advice and guidance.
• Raises potentially significant inspection findings/compliance risks/impact to Senior Management.
• Develops the inspection management plan for each assigned and identified Regulatory Health Authority inspection, in conjunction with the applicable Cross-Functional Team.
• Manage the R&D inspection Framework (Calendars, Distribution Lists, Inspection notifications, SharePoint Sites, Training Content, etc…).
• Liaise with R&D Quality TA Leads to develop appropriate inspection resourcing/scaling and facilities across time-zones, and align TA compliance risk identified contact (CT-RACT, specific risk management items e.g. imaging approaches).
• Support Regulatory Inspection Intelligence processes and provide input into Operational Quality Initiatives.

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.
• Extensive experience in inspection management within the pharmaceutical or biotechnology industry.
• Strong knowledge of global regulatory requirements and inspection processes.
• Excellent communication and presentation skills.
• Proven ability to work effectively in a cross-functional team environment.
• Strong organizational and project management skills.
• Experience with SharePoint and other inspection management tools.
• Ability to provide proactive advice and guidance on inspection management.
• Strong problem-solving skills and the ability to raise issues effectively.
• Ability to travel domestically and/or internationally, depending on business needs, to attend inspections as needed.