22 days old

Sr Manager QA

Amgen
Thousand Oaks, CA 91360
  • Job Code
    114879534
Amgen

Job ID: R-86129
Location: Thousand Oaks, CA, US 91360

Amgen is searching for a Senior Manager QA who will be responsible for leading and managing a team of site lead staff overseeingcontract testing labs and contract manufacturing sites.This Sr. Manager willbe a ccountable for theday to day operations of the group.

The Senior Manager will report to our Director of Quality Assurance for North American Contract Manufacturing Quality.

Key responsibilities for this role include:
  • Accountable for day to day operations of the group
  • Staff member supervision
  • Be an integral quality member of Amgen cross-functional contract manufacturing team that includes but is not limited to business operations, analytical science, process development, supply chain, XPD
  • Partnerwith internal QC network to drive key improvements with contract testing lab process improvement initiatives
  • Lead cross-functional initiatives
  • Interpret SOP and regulatory requirements
  • Set project timelines and priorities
  • Provide guidance and technical advice
  • Drive Operational Excellence and Champion Change
  • Identify and mitigate risks at supplier sites andraise to management as appropriate
  • Allocation of staff and task assignments acrosscontract manufacturer site leads and contract testing lab site leads
  • Approve quality record content
  • Represent Amgen to regulatory authorities
  • Determine holistic plan for improving group performance


Basic Qualifications

Doctorate degree and 2 years of Quality and/or Manufacturing experience

Or

Master's degree and 6 years of Quality and/or Manufacturing experience

Or

Bachelor's degree and 8 years of Quality and/or Manufacturing experience

Or

Associate's degree and 10 years of Quality and/or Manufacturing experience

Or

High school diploma / GED and 12 years of Quality and/or Manufacturing experience

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

  • Bachelor of Science degree
  • 10 + years biotech or pharmaceutical industry experience
  • Quality Controlexperience
  • Direct supervisory experience
  • Ability to facilitate and influence senior partners and balance workload and timelines
  • Ability to negotiate a strategic position after taking feedback from multiple sources
  • Strong project management (PM), problem-solving, and analytical skills & familiarity with PM tools
  • Shown ability to lead cross-functional teams, consistently deliver timely and quality results
  • A record of collaborating and communicating with others & the ability to balance divergent inputs from various partners while driving issue to resolution
  • Ability to operate in a matrixed or team environment with site, functional, and executive leadership
  • Familiarity using the "DAI" decision-making process
  • 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.

PI114879534

<b>Amgen</b><br/><br/><b>Job ID: </b>R-86129<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen is searching for a Senior Manager QA who will be responsible for leading and managing a team of site lead staff overseeingcontract testing labs and contract manufacturing sites.This Sr. Manager willbe a ccountable for theday to day operations of the group. <br><br>The Senior Manager will report to our Director of Quality Assurance for North American Contract Manufacturing Quality.<br><br><b> Key responsibilities for this role include: </b><br><ul><li>Accountable for day to day operations of the group</li><li>Staff member supervision</li><li>Be an integral quality member of Amgen cross-functional contract manufacturing team that includes but is not limited to business operations, analytical science, process development, supply chain, XPD</li><li>Partnerwith internal QC network to drive key improvements with contract testing lab process improvement initiatives</li><li>Lead cross-functional initiatives </li><li>Interpret SOP and regulatory requirements</li><li>Set project timelines and priorities</li><li>Provide guidance and technical advice</li><li>Drive Operational Excellence and Champion Change</li><li>Identify and mitigate risks at supplier sites andraise to management as appropriate</li><li>Allocation of staff and task assignments acrosscontract manufacturer site leads and contract testing lab site leads</li><li>Approve quality record content</li><li>Represent Amgen to regulatory authorities</li><li>Determine holistic plan for improving group performance</li></ul><br><br><b>Basic Qualifications </b><br><br>Doctorate degree and 2 years of Quality and/or Manufacturing experience<br><br>Or<br><br>Master's degree and 6 years of Quality and/or Manufacturing experience<br><br>Or<br><br>Bachelor's degree and 8 years of Quality and/or Manufacturing experience<br><br>Or<br><br>Associate's degree and 10 years of Quality and/or Manufacturing experience<br><br>Or<br><br>High school diploma / GED and 12 years of Quality and/or Manufacturing experience<br><br>AND<br><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><ul><li>Bachelor of Science degree</li><li>10 + years biotech or pharmaceutical industry experience</li><li>Quality Controlexperience </li><li>Direct supervisory experience</li><li>Ability to facilitate and influence senior partners and balance workload and timelines</li><li>Ability to negotiate a strategic position after taking feedback from multiple sources</li><li>Strong project management (PM), problem-solving, and analytical skills & familiarity with PM tools</li><li>Shown ability to lead cross-functional teams, consistently deliver timely and quality results</li><li>A record of collaborating and communicating with others & the ability to balance divergent inputs from various partners while driving issue to resolution</li><li>Ability to operate in a matrixed or team environment with site, functional, and executive leadership</li><li>Familiarity using the "DAI" decision-making process</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/W7rqoehGqRRYCM7jTpBPL"> <p>PI114879534</p>

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

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Sr Manager QA

Amgen
Thousand Oaks, CA 91360

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