23 days old

QA Sr. Manager - Device Site Lead

Amgen
Thousand Oaks, CA 91360
  • Job Code
    115635250
Amgen

Job ID: R-88113
Location: Thousand Oaks, CA, US 91360
Additional Location: US - Rhode Island - West Greenwich

This QA Sr. Manager role will be responsible for the quality oversight of one or more device suppliers. This person is an integral member of the Amgen cross-functional device supplier team that includes, but is not limited to, business operations, final product technologies, process development, supply chain and final product technologies quality.

Key Responsibilities
  • Quality liaison between Amgen and the device supplier
  • Negotiator and Approver of quality agreements
  • Prepare external site for inspections including development of inspection playbooks.
  • Represent Amgen at external supplier site during product-specific Regulatory Inspections and/or during Notified Body audits of supplier, as applicable or required
  • Present on topics during inspection demonstrating appropriate behaviors and knowledge of the subject areas
  • Review/Approve supplier investigations, event and change notifications
  • Quality approver of deviations, change controls, CAPA, CAPA EVs
  • Identify and mitigate risk at the supplier and/or escalate to management
  • Perform Person in Plant activities as required
  • Manage audit commitments to completion
  • Perform tactical batch disposition activities in support of lot release
  • Continuously assess supplier status through periodic monitoring reporting
  • Partner with Operations site lead on issues, improvements, site performance and overall relationship management
  • Domestic and international travel required - on average ~20%


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 Quality experience

Preferred Qualifications
  • 10 + years biotech or pharmaceutical industry experience
  • Experience with Quality Processes and systems such as QMTS and IRPC
  • History of involvement with inspection and audits
  • Able to facilitate and influence senior stakeholders and partners
  • Able to successfully manage workload and timelines
  • Familiarity with basic project management tools
  • Ability to negotiate a strategic position after taking feedback from multiple sources
  • Strong project management, problem-solving, and analytical skills
  • Strong influencing skills
  • Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality results
  • Collaborates and communicates well with others, able to balance divergent inputs from various stakeholders and drive issue resolution
  • Ability to operate in a matrixed or team environment with site, functional, and executive leadership
  • Experience driving decision making by using DAI principles
  • Experience with relationship management with external parties
  • Experience with the "variation management" process


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 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.

PI115635250

<b>Amgen</b><br/><br/><b>Job ID: </b>R-88113<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><b>Additional Location: </b>US - Rhode Island - West Greenwich<br/><br/>This QA Sr. Manager role will be responsible for the quality oversight of one or more device suppliers. This person is an integral member of the Amgen cross-functional device supplier team that includes, but is not limited to, business operations, final product technologies, process development, supply chain and final product technologies quality.<br><br><b> Key Responsibilities </b><br><ul><li>Quality liaison between Amgen and the device supplier</li><li>Negotiator and Approver of quality agreements</li><li>Prepare external site for inspections including development of inspection playbooks.</li><li>Represent Amgen at external supplier site during product-specific Regulatory Inspections and/or during Notified Body audits of supplier, as applicable or required</li><li>Present on topics during inspection demonstrating appropriate behaviors and knowledge of the subject areas</li><li>Review/Approve supplier investigations, event and change notifications</li><li>Quality approver of deviations, change controls, CAPA, CAPA EVs</li><li>Identify and mitigate risk at the supplier and/or escalate to management</li><li>Perform Person in Plant activities as required</li><li>Manage audit commitments to completion</li><li>Perform tactical batch disposition activities in support of lot release</li><li>Continuously assess supplier status through periodic monitoring reporting</li><li>Partner with Operations site lead on issues, improvements, site performance and overall relationship management</li><li>Domestic and international travel required - on average ~20%</li></ul><br><br><b> Basic Qualifications </b><br><br>Doctorate degree and 2 years of Quality experience<br><br>OR<br><br>Master's degree and 6 years of Quality experience<br><br>OR<br><br>Bachelor's degree and 8 years of Quality experience<br><br>OR<br><br>Associate's degree and 10 years of Quality experience<br><br>OR<br><br>High school diploma / GED and 12 years Quality experience<br><br><b> Preferred Qualifications </b><br><ul><li>10 + years biotech or pharmaceutical industry experience</li><li>Experience with Quality Processes and systems such as QMTS and IRPC</li><li>History of involvement with inspection and audits</li><li>Able to facilitate and influence senior stakeholders and partners</li><li>Able to successfully manage workload and timelines</li><li>Familiarity with basic project management tools</li><li>Ability to negotiate a strategic position after taking feedback from multiple sources</li><li>Strong project management, problem-solving, and analytical skills</li><li>Strong influencing skills</li><li>Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality results</li><li>Collaborates and communicates well with others, able to balance divergent inputs from various stakeholders and drive issue resolution</li><li>Ability to operate in a matrixed or team environment with site, functional, and executive leadership</li><li>Experience driving decision making by using DAI principles</li><li>Experience with relationship management with external parties</li><li>Experience with the "variation management" process</li></ul><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 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 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. </b><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/QlJdbJfeNZOAFV65ioraQ"> <p>PI115635250</p>

Categories

Posted: 2019-11-20 Expires: 2019-12-21

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

QA Sr. Manager - Device Site Lead

Amgen
Thousand Oaks, CA 91360

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast