11 days old

Director Corporate Quality GxP Computer Systems and Data Integrity

Amgen
Thousand Oaks, CA 91360
  • Job Code
    115859633
Amgen

Job ID: R-88842
Location: Thousand Oaks, CA, US 91360

The Director Corporate Quality GxP Computer Systems and Data Integrity will serve as a leader of the Corporate Quality GxP team, a multi-discipline group that plans, implements, and supports GxP Computer Systems, Validations and Data Integrity solutions for Operations at Amgen.

Responsibilities:
  • Integrate Amgen's quality and compliance management practices with the enterprise-wide computing system.
  • Lead a team that will participate on working teams to implement new and updated computerized systems and liase between Quality and other key stakeholders.
  • Lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques and procedures.
  • Serve as SME for successful interaction with FDA and other regulatory bodies during site inspections.
  • Develop and conduct appropriate training to ensure Company-wide awareness of Computer Systems Validation and Regulatory requirements
  • Ensure Incorporation of Phase Appropriate Activities for Qualification/Validation while simplifying approaches and maintaining use of programs (i.e. boundary diagrams, change control, paperless Maximo based 'fit for use/qualification processes) for Global Business Applications, Lab Equipment, Equipment and Automation Systems across R&D, Operations, and IS
  • Develop and maintain quality system standards and procedures for computer systems to GxP regulations
  • Develop and track metrics to monitor the health of computerized systems as it relates to data integrity and validation and report to management
  • Develop phase and risk appropriate validation based on use of system
  • Perform industry benchmarking on computerized systems compliance to keep abreast of the everchanging regulatory landscape.
  • Develop validation/qualification package deliverables to ensure standardization across the network and compliance with validation policies and procedures including accurate data analysis.
  • Responsible for hiring, mentoring, and developing team members.
  • Deploy talented, information systems professionals working closely with colleagues to create innovative and effective information solutions.
  • Work in a team matrix environment and independently interact with various levels of management to drive initiatives to completion globally.
  • Work independently to define, lead and implement global improvements to quality systems for computerized systems as well as clearly communicate issues to senior management and affected staff.
  • Serve as a resource to other functional areas in the appropriate use and management of GxP systems Partner with different site functions such as Manufacturing, Engineering, Quality, Executive Management and various support organizations to identify critical business requirements to develop the operations data integrity detection and assurance strategy.
  • Promote the development of forums across departments and sites for training on system utilization and information exchange.


Basic Qualifications

Doctorate degree and 4 years of Information Systems, Quality or Engineering experience

OR

Master's degree and 8 years of Information Systems, Quality or Engineering experience

OR

Bachelor's degree and 10 years of Information Systems, Quality or Engineering 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
  • Demonstrated experience in Computer Validation and Data Integrity within a Quality or Operations organization in the Pharmaceutical, Medical device or Biotech Industries
  • Demonstrated knowledge and expertise in quality management and quality control in clinical and commercial manufacturing
  • Demonstrated working knowledge with the following:
    • GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards
    • Manufacturing information systems in cGMP regulated environments, FDA cGxP and 21 CFR Part 11 regulations, ERP (SAP), Electronic Document Management, Trackwise and Laboratory Systems (LIMS, CDS, LMES)
    • Enterprise business systems delivery, support and service ownership in the areas of Manufacturing, Supply Chain, Quality, Laboratory, and Engineering


  • Strong program leadership skills, including but not limited to the following: client interfacing and resolution of business partner concerns, developing and reporting results, technical guidance, detailed planning, vendor/contract management, validation, technical solution evaluation.
  • Demonstrated ability to handle multiple competing priorities across different business units. Ability to communicate and collaborate with technical and management staff within Manufacturing, Information Systems, Process Development, and Quality.
  • Experience at developing system migration and evolution strategies and turning the strategies into plans which are implemented.
  • Ability to lead a cross functional global network on computer systems and data integrity.


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.

PI115859633

<b>Amgen</b><br/><br/><b>Job ID: </b>R-88842<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>The Director Corporate Quality GxP Computer Systems and Data Integrity will serve as a leader of the Corporate Quality GxP team, a multi-discipline group that plans, implements, and supports GxP Computer Systems, Validations and Data Integrity solutions for Operations at Amgen.<br><br>Responsibilities:<br><ul><li>Integrate Amgen's quality and compliance management practices with the enterprise-wide computing system. </li><li>Lead a team that will participate on working teams to implement new and updated computerized systems and liase between Quality and other key stakeholders.</li><li>Lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques and procedures.</li><li>Serve as SME for successful interaction with FDA and other regulatory bodies during site inspections.</li><li>Develop and conduct appropriate training to ensure Company-wide awareness of Computer Systems Validation and Regulatory requirements</li><li>Ensure Incorporation of Phase Appropriate Activities for Qualification/Validation while simplifying approaches and maintaining use of programs (i.e. boundary diagrams, change control, paperless Maximo based 'fit for use/qualification processes) for Global Business Applications, Lab Equipment, Equipment and Automation Systems across R&D, Operations, and IS</li><li>Develop and maintain quality system standards and procedures for computer systems to GxP regulations</li><li>Develop and track metrics to monitor the health of computerized systems as it relates to data integrity and validation and report to management</li><li>Develop phase and risk appropriate validation based on use of system</li><li>Perform industry benchmarking on computerized systems compliance to keep abreast of the everchanging regulatory landscape.</li><li>Develop validation/qualification package deliverables to ensure standardization across the network and compliance with validation policies and procedures including accurate data analysis. </li><li>Responsible for hiring, mentoring, and developing team members.</li><li>Deploy talented, information systems professionals working closely with colleagues to create innovative and effective information solutions. </li><li>Work in a team matrix environment and independently interact with various levels of management to drive initiatives to completion globally.</li><li>Work independently to define, lead and implement global improvements to quality systems for computerized systems as well as clearly communicate issues to senior management and affected staff. </li><li>Serve as a resource to other functional areas in the appropriate use and management of GxP systems Partner with different site functions such as Manufacturing, Engineering, Quality, Executive Management and various support organizations to identify critical business requirements to develop the operations data integrity detection and assurance strategy.</li><li>Promote the development of forums across departments and sites for training on system utilization and information exchange. </li></ul><br><br><b>Basic Qualifications </b><br><br>Doctorate degree and 4 years of Information Systems, Quality or Engineering experience<br><br>OR<br><br>Master's degree and 8 years of Information Systems, Quality or Engineering experience<br><br>OR<br><br>Bachelor's degree and 10 years of Information Systems, Quality or Engineering 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> Demonstrated experience in Computer Validation and Data Integrity within a Quality or Operations organization in the Pharmaceutical, Medical device or Biotech Industries </li><li>Demonstrated knowledge and expertise in quality management and quality control in clinical and commercial manufacturing</li><li>Demonstrated working knowledge with the following:<ul><li>GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards</li><li>Manufacturing information systems in cGMP regulated environments, FDA cGxP and 21 CFR Part 11 regulations, ERP (SAP), Electronic Document Management, Trackwise and Laboratory Systems (LIMS, CDS, LMES)</li><li>Enterprise business systems delivery, support and service ownership in the areas of Manufacturing, Supply Chain, Quality, Laboratory, and Engineering</li></ul></li></ul><br><br><ul><li>Strong program leadership skills, including but not limited to the following: client interfacing and resolution of business partner concerns, developing and reporting results, technical guidance, detailed planning, vendor/contract management, validation, technical solution evaluation.</li><li>Demonstrated ability to handle multiple competing priorities across different business units. Ability to communicate and collaborate with technical and management staff within Manufacturing, Information Systems, Process Development, and Quality.</li><li>Experience at developing system migration and evolution strategies and turning the strategies into plans which are implemented.</li><li>Ability to lead a cross functional global network on computer systems and data integrity.</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/k5QpogcPgd7Ai7A8i4BJg"> <p>PI115859633</p>

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Posted: 2019-11-27 Expires: 2019-12-28

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Director Corporate Quality GxP Computer Systems and Data Integrity

Amgen
Thousand Oaks, CA 91360

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