Compliance Senior Manager - GCP & PV Auditor
- Employer
- Amgen Inc
- Location
- UK: Cambridge or Uxbridge with flexibility to work from home.
- Salary
- Generous Total Rewards Plan comprising health, finance & wealth, work/life balance &career benefits
- Start date
- 29 Nov 2021
- Closing date
- 29 Dec 2021
View more
- Discipline
- Quality, Auditor
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Management
Job Details
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 ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.
Compliance Senior Manager – GCP / PV Auditor
LIVE
What you will do
In this vital role within R&D Auditing you will be planning and participating in global audits of Amgen’s clinical trials and pharmacovigilance activities. You may also support regulatory inspections of clinical sites and Amgen facilities. The key responsibilities include:
- Plan, conduct and report routine and directed GCP and/or PV compliance audits internationally.
- Serve as a lead auditor for complex GCP and /or PV audit types
- Identify and communicate compliance risks to QA and R&D management
- Host and/or play a role in regulatory authority inspections
- Contribute to or lead QA process improvement initiatives
- Author and contribute to the development of QA cross functional controlled documents
Currently all auditing being conducted remotely, pending easing of travel restrictions the role can entail up to 30% travel to international destinations
Be part of our team
You would be joining Amgen’s R&D Audit Team of expert, professional and widely experienced individuals working with a global remit across Amgen’s portfolio in all stages of development and post marketing.
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:
- Bachelor’s degree in a scientific discipline, medical sciences or pharmacy qualification
- Extensive international auditing conduct experience in GCP and/or Pharmacovigilance or as regulatory authority inspector
- Experience of data mining, manipulation and data analytics would be advantageous
- Excellent written and verbal communication skills
Preferred Qualifications:
- Postgraduate qualification
- Experience supporting regulatory authority inspections
- Participation in process improvement initiatives.
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
LOCATION : UK: Cambridge or Uxbridge with flexibility to work from home.
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
Company
Amgen is committed to unlocking the potential for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.
- Website
- https://www.amgen.com/
- Telephone
- 0031 (0)765786192
- Location
-
One Amgen Center Drive
Thousand Oaks,
California
91320
GB
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