13 days old

Quality Assurance Senior Manager

Amgen
Thousand Oaks, CA 91360
  • Job Code
    116889757
Amgen

Job ID: R-90549
Location: Thousand Oaks, CA, US 91360

The Quality Assurance (QA) Senior Manager will serve as the Amgen Thousand Oaks Quality Leader for Good Manufacturing Practices (GMP) Operations within the Cell Bank, Biosafety Development Laboratory, and the GMP Pilot Plant. The QA Senior Manager will lead a team of QA staff and provide QA leadership and oversight in support of the operational team's key responsibilities which include:
  • Meet site demands for cell bank production for clinical and commercial programs in the cGMP cell bank manufacturing area
  • Meet site demands for drug substance production for clinical programs in the cGMP pilot plant manufacturing area
  • Development, characterization, storage and distribution of critical reagents including but not limited to Antibodies (polyclonal and monoclonal), Host Cell Proteins, Process Impurities, Bioassay Reagents and DNA Reagents
  • Generation of Ready-to-plate (RTP) cell banks for QC Bioassays and troubleshooting
  • GMP clinical testing for viral and adventitious agent testing, including viral clearance studies
  • Identification and Implementation of technologies to improve efficiencies, enabling of new processes and platform processes


The QA Senior Manager will report to the Director of Quality Assurance for Drug Substance (DS) and be a member of the DS QA team that oversees and contributes to serving Amgen patients via DS supply across all the ATO GMP facilities. As a member of this leadership team, the QASenior Manager will contribute to fostering and further developing the culture of Safety and Quality at ATO.

The job responsibilities will include but not be limited to:
  • Staff Management - Maintains the safety of self and others, actively engages with the Amgen EHSS safety program by reporting unsafe conditions if seen and driving improvements, leads a culture of safety. Manages a team of QA professionals and prioritizes professional development of direct reports. Performs staff recruitment and selection, training, oversight, and performance evaluations according to Amgen's talent management program.
  • Quality Oversight and Leadership - Ensures the Quality Management System processes are executed in accordance with established procedures. Provides direction and decision making for Quality system records and report such as investigations, CAPAs, Change Control. Reviews and approves records and reports. May serve as record or report owner. Collaborates cross functionally and across the Amgen Enterprise / Network to ensure the Quality Management System processes are implemented, maintained, and executed in accordance with established procedures and applicable regulations.
  • Continuous Improvement - Serves as a team member with cross-functional colleagues on improvement initiatives, regulatory inspection readiness activities, and internal audits. Collaborates with cross functional staff and colleagues to achieve the objectives of the company in a safe and compliant manner. Engage in Lean Transformation Operational Excellence program to develop stronger capabilities in continuous improvement.
  • Completes required assigned training to permit execution of required tasks
  • Alerts senior management of significant quality, compliance, supply and safety risks
  • May provide leadership and perform additional duties within other areas of the Quality Management System, including but not limited to: Management Review, Audits and Inspections, Change Control, Risk Management


Basic Qualifications:

Doctorate degree and 2 years of Quality or Operations experience

OR

Master's degree and 4 years of Quality or Operations experience

OR

Bachelor's degree and 6 years of Quality or Operations experience

OR

Associates degree and 10 years of Quality or Operations experience

OR

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

Preferred Qualifications:
  • Excellent interpersonal skills
  • Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners
  • Experience participating in, managing, and responding to corporate audits/regulatory inspections
  • Demonstrated ability with project management, initiating and leading cross-functional teams, leading and managing change
  • Strong skills in data analysis skills and business case development
  • Direct experience driving process improvements. Working knowledge of Lean and Six Sigma methodologies a plus
  • Experience with cGMP production environments. Direct work experience with cGMP processes involved in manufacturing and distribution, QA, analytical laboratory, validation, and process development a plus
  • Experience in Cell Banking operations, Cell Culture operations, protein purification and bioassays is a plus
  • Experience with Quality Management Systems, including Change Control, Risk Management, Disposition
  • Experience with Computer Systems such as MES, PI data historian, Delta-V automation systems
  • Experience with TrackWise for supporting investigations and CAPA
  • Biology, Chemistry, or Engineering degree is desirable


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.

PI116889757

<b>Amgen</b><br/><br/><b>Job ID: </b>R-90549<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>The <b>Quality Assurance (QA) Senior Manager</b> will serve as the Amgen Thousand Oaks Quality Leader for Good Manufacturing Practices (GMP) Operations within the Cell Bank, Biosafety Development Laboratory, and the GMP Pilot Plant. The QA Senior Manager will lead a team of QA staff and provide QA leadership and oversight in support of the operational team's key responsibilities which include:<br><ul><li>Meet site demands for cell bank production for clinical and commercial programs in the cGMP cell bank manufacturing area</li><li>Meet site demands for drug substance production for clinical programs in the cGMP pilot plant manufacturing area</li><li>Development, characterization, storage and distribution of critical reagents including but not limited to Antibodies (polyclonal and monoclonal), Host Cell Proteins, Process Impurities, Bioassay Reagents and DNA Reagents</li><li>Generation of Ready-to-plate (RTP) cell banks for QC Bioassays and troubleshooting</li><li>GMP clinical testing for viral and adventitious agent testing, including viral clearance studies</li><li>Identification and Implementation of technologies to improve efficiencies, enabling of new processes and platform processes</li></ul><br><br>The QA Senior Manager will report to the Director of Quality Assurance for Drug Substance (DS) and be a member of the DS QA team that oversees and contributes to serving Amgen patients via DS supply across all the ATO GMP facilities. As a member of this leadership team, the QASenior Manager will contribute to fostering and further developing the culture of Safety and Quality at ATO.<br><br><b>The job responsibilities will include but not be limited to:</b><br><ul><li><b>Staff Management</b> - Maintains the safety of self and others, actively engages with the Amgen EHSS safety program by reporting unsafe conditions if seen and driving improvements, leads a culture of safety. Manages a team of QA professionals and prioritizes professional development of direct reports. Performs staff recruitment and selection, training, oversight, and performance evaluations according to Amgen's talent management program.</li><li><b>Quality Oversight and Leadership</b> - Ensures the Quality Management System processes are executed in accordance with established procedures. Provides direction and decision making for Quality system records and report such as investigations, CAPAs, Change Control. Reviews and approves records and reports. May serve as record or report owner. Collaborates cross functionally and across the Amgen Enterprise / Network to ensure the Quality Management System processes are implemented, maintained, and executed in accordance with established procedures and applicable regulations. </li><li><b>Continuous Improvement</b> - Serves as a team member with cross-functional colleagues on improvement initiatives, regulatory inspection readiness activities, and internal audits. Collaborates with cross functional staff and colleagues to achieve the objectives of the company in a safe and compliant manner. Engage in Lean Transformation Operational Excellence program to develop stronger capabilities in continuous improvement.</li><li>Completes required assigned training to permit execution of required tasks</li><li>Alerts senior management of significant quality, compliance, supply and safety risks</li><li>May provide leadership and perform additional duties within other areas of the Quality Management System, including but not limited to: Management Review, Audits and Inspections, Change Control, Risk Management</li></ul><br><br><b>Basic Qualifications:</b><br><br>Doctorate degree and 2 years of Quality or Operations experience<br><br>OR<br><br>Master's degree and 4 years of Quality or Operations experience<br><br>OR<br><br>Bachelor's degree and 6 years of Quality or Operations experience<br><br>OR<br><br>Associates degree and 10 years of Quality or Operations experience<br><br>OR<br><br>High school diploma / GED and 12 years of Quality or Operations experience<br><br><b>Preferred Qualifications:</b><br><ul><li>Excellent interpersonal skills</li><li>Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners</li><li>Experience participating in, managing, and responding to corporate audits/regulatory inspections</li><li>Demonstrated ability with project management, initiating and leading cross-functional teams, leading and managing change</li><li>Strong skills in data analysis skills and business case development</li><li>Direct experience driving process improvements. Working knowledge of Lean and Six Sigma methodologies a plus</li><li>Experience with cGMP production environments. Direct work experience with cGMP processes involved in manufacturing and distribution, QA, analytical laboratory, validation, and process development a plus</li><li>Experience in Cell Banking operations, Cell Culture operations, protein purification and bioassays is a plus</li><li>Experience with Quality Management Systems, including Change Control, Risk Management, Disposition</li><li>Experience with Computer Systems such as MES, PI data historian, Delta-V automation systems</li><li>Experience with TrackWise for supporting investigations and CAPA</li><li>Biology, Chemistry, or Engineering degree is desirable</li></ul><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/aQ4rKxIo77glc1Qphdp1W"> <p>PI116889757</p>

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Posted: 2020-01-07 Expires: 2020-02-07

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Quality Assurance Senior Manager

Amgen
Thousand Oaks, CA 91360

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