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SalaryHOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
Research andDevelopment Quality GCP Inspection Lead
Live
What you will do
Let’s do this. Let’s change the world. In this vital role you will report to a Clinical Quality Therapeutic area Lead or a Safety & Medical Quality Director and provide critical support to Worldwide Inspection Readiness & Inspection Management efforts. The R&D Quality Inspection lead provides proactive end to end quality oversight strategies for the development and implementation of customized risk-based Inspection Management processes across Research & Development pipeline.
The R&D Quality Inspection Lead will lead and oversee staff and activities in managing Regulatory Authority inspections while serving as the single point of accountability for the overall planning, conduct, follow-up, and closeout of the inspection. The Inspection Lead is responsible for adjusting/scaling inspection roles, responsibilities, staffing for the overall planning, conduct, follow-up, and closeout of the inspection.
You will be a vital role who supports Research & Development as a trusted partner and provides oversight and management of critical data and processes for global inspections. You will help to develop the strategy for and direct the overall management/support for inspections to ensure that all phases of Regulatory Health Authority inspections (i.e. inspection preparation activities, notification, inspection liaison activities during the inspection, development and approval of the inspection responses and implementation of Corrective Action and Preventive Actions (CAPA) Plan) are handled consistently, professionally and proactively and result in outcomes that demonstrate Amgen’s commitment to regulatory compliance.
Responsibilities
Ensures, that as a result 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, Data Management, and other functional areas) 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(s).
Ensures that the R&D inspection Framework (Calendars, Distribution Lists, Inspection notifications, SharePoint Sites, Training Content, Etc.) are up to date and improved with lessons learned over time.
Liaises 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) .
Supports Regulatory Inspection Intelligence processes and provides inpute into Operational Quality Initiatives.
Ensures that Inspection playbooks are updated to remain current to all applicable regulations, and are adapted for complex inspection scenarios (e.g., integration programs, partnership programs, etc.).
Collaborates with Inspection teams from across Amgen to share and learn best practices, and to ensure that all regulatory intelligence is properly ingested, understood, and used for continuous improvement.
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of quality management experience OR
Master’s degree and 6 years of quality management experience OR
Bachelor’s degree and 8 years of quality management experience OR
Associate’s degree and 10 years of quality management experience OR
High school diploma / GED and 12 years of quality management experience
Preferred Qualifications:
At least 3 years of experience in the pharmaceutical/biotech or medical device industry working within quality a quality management system role, or other relevant experience in clinical research that includes quality oversight (e.g., deviation management/CAPA, audit conduct, or inspection support.
An understanding of medical device development and applicable Global Regulations.
An understanding of Precision Medicine and applicable Global Regulations.
An understanding of Quality Management Systems (QMS), including electronic QMS such as Veeva or TrackWise (Sparta Systems).
Experience with compliance to GxP requirements including the oversight of third-party vendors, suppliers, and partners.
Ability to incorporate business and customer feedback into clear, efficient processes using a straightforward language and format.
Strong analytical, critical-thinking, and decision-making abilities, including development and implementation of Analytics methods and technology in order to enable signal detection and quality improvement.
Collaborative worker with an ability to support a high performing team.
Excellent verbal and written communication skills, including strong business writing abilities and active listening.
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
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.
