13 days old

GCP Compliance Manager

Amgen
Thousand Oaks, CA 91360
  • Job Code
    117942318
Amgen

Job ID: R-93484
Location: Thousand Oaks, CA, US 91360
Additional Location: United Kingdom - Uxbridge

As a member of Amgen's R&D Compliance team, the GCP Compliance Manager supports the provision of proactive GCP compliance oversight and guidance to functional areas and stakeholder groups within the R&D organization. This includes providing objective compliance advice and oversight, strengthening and advancing the organization's Quality Management System (QMS) and improving processes through identifying and completing appropriate CAPAs. Specific responsibilities for the GCP Compliance Manager include:
  • Supporting RCA and effectiveness verification activities of CAPAs.
  • Collating and verifying objective evidence for inspection and audit-driven CAPAs.
  • Assessing and managing quality and accuracy of data in R&D CAPA System and providing related compliance reporting and metrics.
  • Supporting GCP inspection readiness and management.
  • Supporting GCP Compliance on governance bodies in the clinical development area.
  • Supporting functional activities including deviation management, inspection readiness and administration of compliance committee.
  • Maintaining knowledge of current regulatory, CAPA and compliance practices/issues.


Basic Qualifications:

Doctorate degree

OR

Master's degree and 3 years of related compliance experience

OR

Bachelor's degree and 5 years of related compliance experience

OR

Associate's degree and 10 years of related compliance experience

OR

High school diploma / GED and 12 years of related compliance experience

Preferred Qualifications:
  • Bachelor's degree in related discipline.
  • Four or more years in biopharmaceutical industry that includes at least two years in GCP compliance.
  • Experience in deviation management (including Root Cause Analysis) in a GCP setting.
  • Experience supporting regulatory authority inspections of GCP.
  • Participation in process improvement initiatives.
  • Knowledge of regulatory authority inspection processes.
  • Knowledge GCP global regulations, processes and operations in the bio-pharmaceutical industry.
  • Understanding of audit/compliance program design.
  • GCP Quality Assurance Qualification/Certification.


Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

PI117942318

<b>Amgen</b><br/><br/><b>Job ID: </b>R-93484<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><b>Additional Location: </b>United Kingdom - Uxbridge<br/><br/>As a member of Amgen's R&D Compliance team, the GCP Compliance Manager supports the provision of proactive GCP compliance oversight and guidance to functional areas and stakeholder groups within the R&D organization. This includes providing objective compliance advice and oversight, strengthening and advancing the organization's Quality Management System (QMS) and improving processes through identifying and completing appropriate CAPAs. Specific responsibilities for the GCP Compliance Manager include:<br><ul><li>Supporting RCA and effectiveness verification activities of CAPAs.</li><li>Collating and verifying objective evidence for inspection and audit-driven CAPAs.</li><li>Assessing and managing quality and accuracy of data in R&D CAPA System and providing related compliance reporting and metrics.</li><li>Supporting GCP inspection readiness and management.</li><li>Supporting GCP Compliance on governance bodies in the clinical development area.</li><li>Supporting functional activities including deviation management, inspection readiness and administration of compliance committee.</li><li>Maintaining knowledge of current regulatory, CAPA and compliance practices/issues.</li></ul><br><br>Basic Qualifications:<br><br>Doctorate degree<br><br>OR<br><br>Master's degree and 3 years of related compliance experience<br><br>OR<br><br>Bachelor's degree and 5 years of related compliance experience<br><br>OR<br><br>Associate's degree and 10 years of related compliance experience<br><br>OR<br><br>High school diploma / GED and 12 years of related compliance experience<br><br>Preferred Qualifications:<br><ul><li>Bachelor's degree in related discipline.</li><li>Four or more years in biopharmaceutical industry that includes at least two years in GCP compliance.</li><li>Experience in deviation management (including Root Cause Analysis) in a GCP setting.</li><li>Experience supporting regulatory authority inspections of GCP.</li><li>Participation in process improvement initiatives.</li><li>Knowledge of regulatory authority inspection processes.</li><li>Knowledge GCP global regulations, processes and operations in the bio-pharmaceutical industry.</li><li>Understanding of audit/compliance program design.</li><li>GCP Quality Assurance Qualification/Certification.</li></ul><br> <br> Join Us <br> <br> If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. <br> <br> Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. <br> <br> As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. <br> <br> Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.<br/><br/> <img src="https://analytics.click2apply.net/v/E56gpLiMGJXRfY5bsXman"> <p>PI117942318</p>

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Posted: 2020-02-11 Expires: 2020-03-13

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GCP Compliance Manager

Amgen
Thousand Oaks, CA 91360

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