Quality Compliance Senior Manager - Inspections GCP
Quality Compliance Senior Manager - Inspections GCP
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Job Description
Career Category
RegulatoryJob Description
HOW MIGHT YOU DEFY IMAGINATION
If you feel like youre part of something bigger its because you are. At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching manufacturing and delivering everbetter products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.
QUALITY COMPLIANCE SENIOR MANAGER INSPECTIONS (GCP)
LIVE
What you will do
In this vital role you will provide proactive end to end quality support for the development and implementation of a riskbased quality assurance strategy for all stages of products in the clinical development program. This role focuses on preparation and management for Regulatory Inspections and advise on responses including root cause analysis and CAPA plans.
- Serve as a Good Clinical Practices (GCP) Subject Matter Expert providing independent quality guidance for clinical trials
- Plan conduct and report out on riskbased GCP audits (investigator site audits affiliate audits service provider audits and study level audits) or support outsourced audits
- Support global and local clinical trial teams for all quality management activities including management of quality events (e.g. Deviations/CAPAs Serious Breaches/Privacy Issues Inspection Readiness activities and Inspection Management)
- Ensure quality oversight for the Risk Assessment Categorization Tool (RACT) to identify and mitigate trial risk
- Support monthly meetings with clinical program leaders to review quality and compliance risks including deviations trends filing timelines inspections and crossprogram risks
- Conduct new vendor qualifications in a riskbased manner
- Analyze data quality trends address areas of weakness and gaps implement and communicate key quality metrics
- Coordinate and support key technologies for data collection and measurement (e.g. biomarker usage and imaging methods)
Be part of our team
You will join a global dynamic and expanding team operating within one of the following therapy areas: Oncology Rare Disease General Medicine Biosimilars and Inflammation. You will report to the Therapeutic Area Quality Lead Clinical & Research Quality (CRQ).
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:
- Experience in Quality Management Quality Assurance or other relevant riskbased quality practices in the pharmaceutical/biotech industry
- Quality Oversight of Clinical Trials including protocol development and submissions
- Expert in GCP with extensive experience in inspection planning including timeline management mock inspections and interview preparation.
- Expertise in Quality Management Systems (QMS) including electronic systems like Veeva or TrackWise
- Solid understanding of Clinical R&D global regulations and regulatory submissions
- Experience with leading Regulatory Agency inspections including managing preinspection requests storyboarding Front Room and Back Room management and responses to inspection findings (root cause analysis CAPA etc..
- Excellent communication active listening strong analytical and decisionmaking skills
- Leadership or mentoring experience is considered a plus
- Degree educated
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 wellbeing.
- 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 regular office work either from our Cambridge or Uxbridge next generation workspace.
APPLY NOW
for a career that defies imagination
In our quest to serve patients above all else Amgen is the first to imagine and the last to doubt. Join us.
careers.amgen
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.
.Required Experience:
Senior Manager
Employment Type
Full-Time
