18 days old

Regulatory Operations Process Excellence Sr Mgr

Amgen
Thousand Oaks, CA 91360
  • Job Code
    118953554
Amgen

Job ID: R-95911
Location: Thousand Oaks, CA, US 91360
Additional Location: United Kingdom - Cambridge, United Kingdom - Uxbridge

Amgen is seeking a Regulatory Operations Process Excellence Sr Manager to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more:

This role is responsible for the following duties:

Drive continuous improvement across GRO by applying best continuous process improvement practices in support of Amgen strategic imperatives and external drivers

Drive operational excellence by ensuring application of best practices for training and documentation for GRO functions

Proactively inserting group expertise in support of GRO Functional process improvements

Lead and facilitate process improvement efforts

Drive optimal process documentation and training materials

GRO continuous improvement center of excellence

Provide tools, process and resources to monitor the health of internal regulatory processes (i.e. network KCIs, data quality reports, document authoring, etc.)

Analyze metrics and recommend process improvements across GRO processes to GRO SMT and wider networks

Driver of process updates by driving functional and/or cross functional project team of SME

Process experts, that help facilitate continuous process improvement efforts

Six sigma expertise (up to and including black belt)

Lead GRO deviation management by partnering with compliance to manage deviations/ CAPAs through completion

Lead the recruitment, training, and development of Staff

Lead and facilitate process documentation and training updates across GRO

Drive AMGEN RIM process documentation and training updates in alignment with cross functional SMEs by communicating system updates and partnering to understand and identify impact

Manage the day to day operations of Process & Deviations Excellence Team:

Line management of system governance, training & documentation group

Basic Qualifications:
Doctorate degree and 2 years of Regulatory, Pharmaceutical or Biotech experience

OR

Master's degree and 4 years of Regulatory, Pharmaceutical or Biotech experience

OR

Bachelor's degree and 6 years of Regulatory, Pharmaceutical or Biotech experience

OR

Associate's degree and 10 years of Regulatory, Pharmaceutical or Biotech experience

OR

High school diploma / GED and 12 years of Regulatory, Pharmaceutical or Biotech experience

Preferred Qualifications:

5 years of experience leading projects, programs or directing the allocation of resources

2 years of regulated industry (Pharmaceutical/biotech preferred) experience in an operationally focused role

Demonstrates leadership attributes: charts the course, develop best team, role model

Familiarity with regulatory processes and procedures globally

Project management experience (PMP certification)

Six Sigma and/ or Lean Six Sigma (black belt certification) or other process improvement techniques and tool

Amgen is committed to unlocking the potential of biology 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.

Amgen provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow.

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.

PI118953554

<b>Amgen</b><br/><br/><b>Job ID: </b>R-95911<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><b>Additional Location: </b>United Kingdom - Cambridge, United Kingdom - Uxbridge<br/><br/>Amgen is seeking a <b>Regulatory Operations Process Excellence Sr Manager</b> to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more: <br><br>This role is responsible for the following duties:<br><br>Drive continuous improvement across GRO by applying best continuous process improvement practices in support of Amgen strategic imperatives and external drivers<br><br>Drive operational excellence by ensuring application of best practices for training and documentation for GRO functions<br><br>Proactively inserting group expertise in support of GRO Functional process improvements<br><br>Lead and facilitate process improvement efforts<br><br>Drive optimal process documentation and training materials<br><br>GRO continuous improvement center of excellence<br><br>Provide tools, process and resources to monitor the health of internal regulatory processes (i.e. network KCIs, data quality reports, document authoring, etc.)<br><br>Analyze metrics and recommend process improvements across GRO processes to GRO SMT and wider networks<br><br>Driver of process updates by driving functional and/or cross functional project team of SME<br><br>Process experts, that help facilitate continuous process improvement efforts<br><br>Six sigma expertise (up to and including black belt)<br><br>Lead GRO deviation management by partnering with compliance to manage deviations/ CAPAs through completion<br><br>Lead the recruitment, training, and development of Staff<br><br>Lead and facilitate process documentation and training updates across GRO<br><br>Drive AMGEN RIM process documentation and training updates in alignment with cross functional SMEs by communicating system updates and partnering to understand and identify impact<br><br>Manage the day to day operations of Process & Deviations Excellence Team:<br><br>Line management of system governance, training & documentation group<br><br><b>Basic Qualifications:</b><br>Doctorate degree and 2 years of Regulatory, Pharmaceutical or Biotech experience<br><br>OR<br><br>Master's degree and 4 years of Regulatory, Pharmaceutical or Biotech experience<br><br>OR<br><br>Bachelor's degree and 6 years of Regulatory, Pharmaceutical or Biotech experience<br><br>OR<br><br>Associate's degree and 10 years of Regulatory, Pharmaceutical or Biotech experience<br><br>OR<br><br>High school diploma / GED and 12 years of Regulatory, Pharmaceutical or Biotech experience<br><br>Preferred Qualifications:<br><br>5 years of experience leading projects, programs or directing the allocation of resources<br><br>2 years of regulated industry (Pharmaceutical/biotech preferred) experience in an operationally focused role<br><br>Demonstrates leadership attributes: charts the course, develop best team, role model<br><br>Familiarity with regulatory processes and procedures globally<br><br>Project management experience (PMP certification)<br><br>Six Sigma and/ or Lean Six Sigma (black belt certification) or other process improvement techniques and tool<br><br><b>Amgen </b>is committed to unlocking the potential of biology 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.<br><br><b>Amgen</b> 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.<br><br><b> Amgen </b> provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow. <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/QlYm2YIg6BOAhV65ioraQ"> <p>PI118953554</p>

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Posted: 2020-03-12 Expires: 2020-04-12

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Regulatory Operations Process Excellence Sr Mgr

Amgen
Thousand Oaks, CA 91360

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