Quality Compliance Senior Manager
Quality Compliance Senior Manager
Posted on :
03-03-2025
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1 Vacancy
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Job Description
Job Title: Quality Compliance Senior Manager
Job Location: Cambridge UK
Job Location Type: Hybrid
Job Contract Type: Fulltime
Job Seniority Level:
HOW 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 everbetter products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.
QUALITY COMPLIANCE SENIOR MANAGER
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. You will support global and local study teams and all clinical trial sites who participate in Amgen sponsored trials.
We are hiring two Quality Compliance Senior Managers each one will be joining a dynamic and expanding team operating within one of the following therapy areas: General Medicine Biosimilars and/or Inflammation.
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:
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.
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.com
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.
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 everbetter products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.
QUALITY COMPLIANCE SENIOR MANAGER
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. You will support global and local study teams and all clinical trial sites who participate in Amgen sponsored trials.
- 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
- Manage quality events and regulatory inspections and advise on responses including root cause analysis and CAPA plans
- 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)
We are hiring two Quality Compliance Senior Managers each one will be joining a dynamic and expanding team operating within one of the following therapy areas: General Medicine Biosimilars and/or Inflammation.
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
- Expertise in Quality Management Systems (QMS) including electronic systems like Veeva or TrackWise
- Strong knowledge of Clinical R&D global regulations and regulatory submissions
- Quality Oversight of Clinical Trials including protocol development execution and submissions
- Experience within GCP including conducting audits and managing inspections
- Excellent communication active listening strong analytical and decisionmaking skills
- Leadership or mentoring experience is considered a plus
- Degree educated
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
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.com
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.
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Employment Type
Full Time
Key Skills
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