R&D Quality Senior Manager

Career Category

Job Description

Join our team at Amgen Capability Center Portugal the #1 company in Best Workplaces (201500 employees category) in 2024 by the Great Place to Work Institute. With over 400 talented individuals from more than 40 nationalities our Lisbon center thrives at the intersection of innovation excellence and inspiration. This is your opportunity to explore the future of healthcare through technology and digital innovation supporting our mission To Serve Patients.

R&D QUALITY SENIOR MANAGER

LIVE

What you will do

Lets do this! Lets 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.

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.

• 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.

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.

• Flexible work arrangements.

Objects in your future are closer than they appear. Join us.

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 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 accommodation.