9 days old

Director Quality Management Systems

Amgen
Thousand Oaks, CA 91360
  • Job Code
    116922695
Amgen

Job ID: R-90615
Location: Thousand Oaks, CA, US 91360

The Quality Director will report directly to the Amgen Thousand Oaks (ATO) Quality Site Head and provide management and oversight for the following areas: ATO site Quality Management System (QMS) functions and processes, including but not limited to Change Control, Document Management, Learning & Performance, Risk Management, Management Review, Deviations/CAPA, Metrics, various Process Development processes and all other processes as needed under Amgen's QMS.

Job Responsibilities:
  • Ensuring ATO's QMS processes are appropriately designed, implemented and managed to ensure they are "Fit For Purpose" for effective, controlled practices in phase appropriate, process development processes and in Clinical and Commercial manufacturing at ATO•Ensuring appropriate
  • Escalation of key QMS topics to senior management, thru well run Management Reviews
  • Ensuring ATO leadership in external industry and regulatory influencing
  • Ensuring a team of dedicated QMS SMEs are active and leading in Amgen's global QMS networks and influences Amgen's overall QMS strategy
  • Implement and maintain the QMS across the ATO site in accordance with Amgen policies, standards and regulatory requirements and guidance
  • Develop, implement and maintain the appropriate QMS(s) suitable to ATO's diverse responsibilities. Ensure "Fit for Purpose" QMS standards for Process Development, and for Clinical/Commercial mfg
  • Ensure an adequate number of qualified personnel who possess the necessary combination of skills, knowledge and experience and ensures that training are provided to perform assigned Quality functions in accordance with the requirements and regulations.
  • Alerts Quality leadership of any significant quality, compliance, supply and safety risks
  • Coordinating, leading and facilitating ATO Site and Process Development functional Mgmt Reviews
  • Leading and coordinating participation in external industry groups and conferences. Representing Amgen accordingly, to influence appropriate external regulations
  • Lead ATO representation on company-wide networks and hires/develops a strong team of QMS experts (SMEs) that are learning from peer sites and influencing strategy
  • Translates external regulations into understandable and implementable processes at ATO
  • Based on execution performance, proposes and implements Continuous Improvement and Productivity initiatives, programs and projects.
  • Actively participate in site QLT to support routine site operations, MAP, TMP and succession planning, prioritization and project assessment with a One Amgen approach.


Basic Qualifications:

Doctorate degree and 4 years of Quality, Life Sciences or Operations experience
OR
Master's degree and 8 years of Quality Life Sciences or Operations experience
OR
Bachelor's degree and 10 years of Quality, Life Sciences 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:
  • 10+ years site based experience (Manufacturing, Process Development, or Quality Assurance) in the pharmaceutical/biotech industry
  • Work in a team matrix environment and independently interact with various levels of management
  • Excellent communication skills, both written and oral,
  • Broad and deep knowledge of ICH Q10 and associated global standards
  • Deep knowledge of Quality Assurance functions and practices across a broad range of manufacturing and supply chain processes
  • Strong QC laboratory knowledge
  • Ability to plan, monitor, and control a set of projects, ensuring efficient utilization of resources to achieve program objectives
  • Ability to effectively present information to all levels of the organization with appropriate messaging and effective focus on desired outcomes.
  • Autonomous thinker, willing to take informed and appropriate risks
  • Innovation mindset with aptitude for developing ideas into actionable objectives


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.

PI116922695

<b>Amgen</b><br/><br/><b>Job ID: </b>R-90615<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>The Quality Director will report directly to the Amgen Thousand Oaks (ATO) Quality Site Head and provide management and oversight for the following areas: ATO site Quality Management System (QMS) functions and processes, including but not limited to Change Control, Document Management, Learning & Performance, Risk Management, Management Review, Deviations/CAPA, Metrics, various Process Development processes and all other processes as needed under Amgen's QMS.<br><br><b>Job Responsibilities:</b><br><ul><li>Ensuring ATO's QMS processes are appropriately designed, implemented and managed to ensure they are "Fit For Purpose" for effective, controlled practices in phase appropriate, process development processes and in Clinical and Commercial manufacturing at ATOEnsuring appropriate</li><li>Escalation of key QMS topics to senior management, thru well run Management Reviews</li><li>Ensuring ATO leadership in external industry and regulatory influencing</li><li>Ensuring a team of dedicated QMS SMEs are active and leading in Amgen's global QMS networks and influences Amgen's overall QMS strategy</li><li>Implement and maintain the QMS across the ATO site in accordance with Amgen policies, standards and regulatory requirements and guidance</li><li>Develop, implement and maintain the appropriate QMS(s) suitable to ATO's diverse responsibilities. Ensure "Fit for Purpose" QMS standards for Process Development, and for Clinical/Commercial mfg</li><li>Ensure an adequate number of qualified personnel who possess the necessary combination of skills, knowledge and experience and ensures that training are provided to perform assigned Quality functions in accordance with the requirements and regulations.</li><li>Alerts Quality leadership of any significant quality, compliance, supply and safety risks</li><li>Coordinating, leading and facilitating ATO Site and Process Development functional Mgmt Reviews</li><li>Leading and coordinating participation in external industry groups and conferences. Representing Amgen accordingly, to influence appropriate external regulations</li><li>Lead ATO representation on company-wide networks and hires/develops a strong team of QMS experts (SMEs) that are learning from peer sites and influencing strategy</li><li>Translates external regulations into understandable and implementable processes at ATO</li><li>Based on execution performance, proposes and implements Continuous Improvement and Productivity initiatives, programs and projects.</li><li>Actively participate in site QLT to support routine site operations, MAP, TMP and succession planning, prioritization and project assessment with a One Amgen approach.</li></ul><br><br><b>Basic Qualifications:</b><br><br>Doctorate degree and 4 years of Quality, Life Sciences or Operations experience<br>OR<br>Master's degree and 8 years of Quality Life Sciences or Operations experience<br>OR<br>Bachelor's degree and 10 years of Quality, Life Sciences or Operations experience<br>AND<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>10+ years site based experience (Manufacturing, Process Development, or Quality Assurance) in the pharmaceutical/biotech industry</li><li>Work in a team matrix environment and independently interact with various levels of management</li><li>Excellent communication skills, both written and oral,</li><li>Broad and deep knowledge of ICH Q10 and associated global standards</li><li>Deep knowledge of Quality Assurance functions and practices across a broad range of manufacturing and supply chain processes</li><li>Strong QC laboratory knowledge</li><li>Ability to plan, monitor, and control a set of projects, ensuring efficient utilization of resources to achieve program objectives</li><li>Ability to effectively present information to all levels of the organization with appropriate messaging and effective focus on desired outcomes.</li><li>Autonomous thinker, willing to take informed and appropriate risks</li><li>Innovation mindset with aptitude for developing ideas into actionable objectives<br></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/BXboNZfMyojmspB2iRrwl"> <p>PI116922695</p>

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

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Director Quality Management Systems

Amgen
Thousand Oaks, CA 91360

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