11 days old

Director, Quality Control

Amgen
West Greenwich, RI 02817
  • Job Code
    116922954
Amgen

Job ID: R-90920
Location: West Greenwich, RI, US 02817

Amgen is seeking a Director of Quality at its West Greenwich, RI site to join the Quality Control Unit. The Directorwill report to the Executive Director of Quality for Commercial Operations.

Primary focus as the Director Quality Control (QC) is to successfully provide oversight of analytical testing in support of bulk manufacturing and fill/finish operations across a diverse release and stability testing portfolio.

Key responsibilities for the Director of Quality include:
  • Ensure investigations are conducted in a timely manner with thorough Root Cause Analysis and effective Corrective Actions/Preventative Actions (CAPAs)
  • Partner with other functional area leads across Process Development, Attributes Sciences, QC network and Product Quality to effectively execute method transfers and validations
  • Represent QC organization in related Network teams and company-wide initiatives
  • Ensure compliance with procedures relating to area of responsibilities
  • Participate in regulatory inspections and site audits; lead QC activities during regulatory inspections, including inspection management and response strategies


Basic Qualifications

Doctorate degree and 4 years of Quality or Operations experience

OR

Master's degree and 8 years of Quality or Operations experience

OR

Bachelor's degree and 10 years of Quality or Operations experience

AND

4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications
  • 15 + years' pharmaceutical industry experience in Quality, Manufacturing, Engineering or Process Development
  • Able to facilitate and influence clients and partners
  • Able to successfully manage workload to timelines
  • Familiarity with basic project management tools and lean
  • Ability to interpret regulations
  • Expert knowledge of quality processes and Quality Control operations
  • Strong working knowledge of Current Good Manufacturing Practices (cGMPs) and regulatory expectations related to QC roles and responsibilities


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.

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.

PI116922954

<b>Amgen</b><br/><br/><b>Job ID: </b>R-90920<br/><b>Location: </b>West Greenwich, RI, US 02817<br/><br/>Amgen is seeking a Director of Quality at its West Greenwich, RI site to join the Quality Control Unit. The Directorwill report to the Executive Director of Quality for Commercial Operations.<br><br>Primary focus as the Director Quality Control (QC) is to successfully provide oversight of analytical testing in support of bulk manufacturing and fill/finish operations across a diverse release and stability testing portfolio.<br><br><b> Key responsibilities for the Director of Quality include: </b><br><ul><li>Ensure investigations are conducted in a timely manner with thorough Root Cause Analysis and effective Corrective Actions/Preventative Actions (CAPAs)</li><li>Partner with other functional area leads across Process Development, Attributes Sciences, QC network and Product Quality to effectively execute method transfers and validations</li><li>Represent QC organization in related Network teams and company-wide initiatives</li><li>Ensure compliance with procedures relating to area of responsibilities</li><li>Participate in regulatory inspections and site audits; lead QC activities during regulatory inspections, including inspection management and response strategies</li></ul><br><br><b>Basic Qualifications </b><br><br>Doctorate degree and 4 years of Quality or Operations experience<br><br>OR<br><br>Master's degree and 8 years of Quality or Operations experience<br><br>OR<br><br>Bachelor's degree and 10 years of Quality or Operations experience<br><br>AND<br><br>4 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><ul><li>15 + years' pharmaceutical industry experience in Quality, Manufacturing, Engineering or Process Development</li><li>Able to facilitate and influence clients and partners</li><li>Able to successfully manage workload to timelines</li><li>Familiarity with basic project management tools and lean</li><li>Ability to interpret regulations</li><li>Expert knowledge of quality processes and Quality Control operations</li><li>Strong working knowledge of Current Good Manufacturing Practices (cGMPs) and regulatory expectations related to QC roles and responsibilities</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>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/dalGKOCXq7yacJzgi1Pmz"> <p>PI116922954</p>

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Posted: 2020-01-08 Expires: 2020-02-08

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Director, Quality Control

Amgen
West Greenwich, RI 02817

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