25 days old

GVP Compliance Manager

Amgen
Thousand Oaks, CA 91360
  • Job Code
    114879601
Amgen

Job ID: R-86467
Location: Thousand Oaks, CA, US 91360
Additional Location: United Kingdom - Cambridge, United Kingdom - Uxbridge

As a member of Amgen's R&D Compliance team, the Good Pharmacovigilance Practices (GVP) Compliance Manager will be responsible for strengthening and advancing the organization's QMS through:
  • Improving R&D processes through contribution of expertise in identifying appropriate CAPAs.
  • Identifying CAPA trends and enabling timely completion of CAPAs and status reports.
  • Ensure quality of data in R&D CAPA System.
  • Supporting objective compliance advice and oversight to the business for GVP activities.


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 a minimum of two years in GVP compliance.
  • Experience in exception management (including Root Cause Analysis) in a GVP setting.
  • Experience supporting regulatory authority inspections of GVP.
  • Participation in process improvement initiatives.
  • Knowledge of regulatory authority inspection processes.
  • Knowledge GVP global regulations, processes and operations in the bio-pharmaceutical industry.
  • Understanding of audit/compliance program design.
  • GVP 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.

PI114879601

<b>Amgen</b><br/><br/><b>Job ID: </b>R-86467<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><b>Additional Location: </b>United Kingdom - Cambridge, United Kingdom - Uxbridge<br/><br/>As a member of Amgen's R&D Compliance team, the Good Pharmacovigilance Practices (GVP) Compliance Manager will be responsible for strengthening and advancing the organization's QMS through:<br><ul><li>Improving R&D processes through contribution of expertise in identifying appropriate CAPAs.</li><li>Identifying CAPA trends and enabling timely completion of CAPAs and status reports.</li><li>Ensure quality of data in R&D CAPA System.</li><li>Supporting objective compliance advice and oversight to the business for GVP activities.</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 a minimum of two years in GVP compliance.</li><li>Experience in exception management (including Root Cause Analysis) in a GVP setting.</li><li>Experience supporting regulatory authority inspections of GVP.</li><li>Participation in process improvement initiatives.</li><li>Knowledge of regulatory authority inspection processes.</li><li>Knowledge GVP global regulations, processes and operations in the bio-pharmaceutical industry.</li><li>Understanding of audit/compliance program design.</li><li>GVP 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/z14YgZhX1R1dS7oqibe5x"> <p>PI114879601</p>

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Posted: 2019-10-25 Expires: 2019-11-25

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GVP Compliance Manager

Amgen
Thousand Oaks, CA 91360

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