16 days old

Global Process Owner, Management Responsibilities and Risk management

Amgen
Thousand Oaks, CA 91360
  • Job Code
    119209677
Amgen

Job ID: R-90590
Location: Thousand Oaks, CA, US 91360

The Quality Management System is the foundation of all that we manufacture, test, and store at Amgen to support our biggest mission, to serve the patients. This position willlead efforts to assure our quality management system (QMS) is suitable, adequate, and effective. This position will also oversee the integration of risk management into the QMS. This position will participate in the transformation of the QMS to support Amgen's product types and phases. This position sits in Corporate Quality Systems, interfaces with senior leadership, and is involved with the QMS strategy.

This position is based in Thousand Oaks, but other Amgen locations will be considered.

Responsibilities:

Owns the Quality Manual, Management Review, Risk Management, and Standards processes. Also owns the Process Overview and Multisite SOP's for these processes. Assures alignment with document hierarchy and document templates

Coordinates and compiles the QLT andCorporate level management review to assure senior leadership can maintain a suitable and effective QMS.

Owns and acts upon performance metrics and process issues, implementing actions to drive continuous improvement and escalating to management for support if needed

Leads and coordinates critical activities to ensure compliance throughout the network: gap assessments, commitments, response to audit & inspection findings and deviations

Leads continuous process improvements and partners with network SME's on key initiatives

Supports regulatory inspections and audits

Maintains assigned global quality process in compliance with all applicable global regulations and global Amgen specific requirements

Monitors GMP Surveillance and takes necessary actions to align process to applicable new or revised regulatory requirements

Leads network and cascades requirements and QMS architecture down to all applicable sites and functions. Notifies sites early of changes to ensure consistency

Basic Qualifications:

Doctorate degree and 2 years of Quality experience
OR
Master's degree and 6 years of Quality experience
OR
Bachelor's degree and 8 years of Quality experience
OR
Associate's degree and 10 years of Quality experience
OR
High school diploma / GED and 12 years of Qualityexperience
AND
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

•7+ years of leadership experience managing teams across global sites and functions

•Advanced knowledge Quality Management Systems

•Experience in a pharmaceutical/drug/device manufacturing environment

•4 years of leading quality initiatives or processes across a global network

•Experience in a pharmaceutical/drug/device manufacturing environment

•Ability to balance and interpret global priorities and market appropriate requirements to ensure Quality System elements are Agile and phase appropriate

•Autonomous thinker, willing to take informed and appropriate risks

•Broad and deep knowledge of the Amgen Quality Management System (QMS)

•Understand global, regional and local commercial business (speak commercial)

•Cultural awareness and dexterity

•English language fluency- other language skills are an advantage

•Innovation mindset with aptitude for developing ideas into actionable objectives

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 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.

We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

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.

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.

PI119209677

<b>Amgen</b><br/><br/><b>Job ID: </b>R-90590<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>The Quality Management System is the foundation of all that we manufacture, test, and store at Amgen to support our biggest mission, to serve the patients. This position willlead efforts to assure our quality management system (QMS) is suitable, adequate, and effective. This position will also oversee the integration of risk management into the QMS. This position will participate in the transformation of the QMS to support Amgen's product types and phases. This position sits in Corporate Quality Systems, interfaces with senior leadership, and is involved with the QMS strategy.<br><br>This position is based in Thousand Oaks, but other Amgen locations will be considered.<br><br>Responsibilities:<br><br>Owns the Quality Manual, Management Review, Risk Management, and Standards processes. Also owns the Process Overview and Multisite SOP's for these processes. Assures alignment with document hierarchy and document templates<br><br>Coordinates and compiles the QLT andCorporate level management review to assure senior leadership can maintain a suitable and effective QMS.<br><br>Owns and acts upon performance metrics and process issues, implementing actions to drive continuous improvement and escalating to management for support if needed<br><br>Leads and coordinates critical activities to ensure compliance throughout the network: gap assessments, commitments, response to audit & inspection findings and deviations<br><br>Leads continuous process improvements and partners with network SME's on key initiatives<br><br>Supports regulatory inspections and audits<br><br>Maintains assigned global quality process in compliance with all applicable global regulations and global Amgen specific requirements<br><br>Monitors GMP Surveillance and takes necessary actions to align process to applicable new or revised regulatory requirements<br><br>Leads network and cascades requirements and QMS architecture down to all applicable sites and functions. Notifies sites early of changes to ensure consistency<br><br><b>Basic Qualifications</b>:<br><br>Doctorate degree and 2 years of Quality experience<br>OR<br>Master's degree and 6 years of Quality experience<br>OR<br>Bachelor's degree and 8 years of Quality experience<br>OR<br>Associate's degree and 10 years of Quality experience<br>OR<br>High school diploma / GED and 12 years of Qualityexperience<br>AND<br>2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources<br><br><b>Preferred Qualifications</b>:<br><br>7+ years of leadership experience managing teams across global sites and functions<br><br>Advanced knowledge Quality Management Systems<br><br>Experience in a pharmaceutical/drug/device manufacturing environment<br><br>4 years of leading quality initiatives or processes across a global network<br><br>Experience in a pharmaceutical/drug/device manufacturing environment<br><br>Ability to balance and interpret global priorities and market appropriate requirements to ensure Quality System elements are Agile and phase appropriate<br><br>Autonomous thinker, willing to take informed and appropriate risks<br><br>Broad and deep knowledge of the Amgen Quality Management System (QMS)<br><br>Understand global, regional and local commercial business (speak commercial)<br><br>Cultural awareness and dexterity<br><br>English language fluency- other language skills are an advantage<br><br>Innovation mindset with aptitude for developing ideas into actionable objectives<br><br>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.<br><br>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.<br><br>We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.<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>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/dambqrsX2KkJTJzgi1Pmz"> <p>PI119209677</p>

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Posted: 2020-03-21 Expires: 2020-04-21

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Global Process Owner, Management Responsibilities and Risk management

Amgen
Thousand Oaks, CA 91360

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