1+ months

Executive Director Quality, Product Complaints and Surveillance

Amgen
Thousand Oaks, CA 91360
  • Job Code
    115347591
Amgen

Job ID: R-87655
Location: Thousand Oaks, CA, US 91360

Executive Director Quality, Product Complaints and Surveillance

The Executive Director Quality is responsible for leading the strategy and execution of Quality oversight for the global complaint business process and management system at Amgen. This role will report to the Vice President, Final Product Quality and Surveillance and assures complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. The position Interfaces directly with agencies during inspections and provides response to agency requests regarding the complaints process and leads the team through the development of requirements and ensures procedures are in place for the complaint management system. He/She will work closely with global regulatory and safety leadership to assure complaints business process is adapted to emerging trends or new requirements in regulations while working in close partnership with internal Amgen leadership and executive management beyond Operations to ensure successful issues resolution and continuous improvement. He/She will alert and advise executive management on significant Quality, compliance, supply and safety risks and provide authoritative advice to top management based on deep subject matter expertise in Quality while being accountable to develop and lead a global team that provides Quality oversight and is responsible for the management of product complaints. He/She will ensure that there is an adequate number of qualified personnel who possess a combination of education, experience and training to perform the work in accordance with requirements and specifications.

Key Responsibilities
  • Oversight of global complaints business process management and continuous improvement, including setting the global strategy for complaints management
  • Maintains oversight of complaints throughout the life cycle from intake, processing, and through closure
  • Assure proper program design is used to assign site assessments for complaints
  • Applies in-depth knowledge and subject matter expertise to determine the steps necessary to advance the quality system in order to address complaint causes
  • Provides accurate and robust surveillance information that meets global health authorities and Amgen requirements
  • Leverages expertise and effectively engages with technical functions to translate risk assessments into complaint codes and decision trees and ensure continual alignment with regulatory filings
  • Oversight of internal lab operations for investigations of return complaint samples
  • Manage data sources used for trending, provide necessary data to technical teams for advanced analysis
  • Ensure there is alignment between linked product complaint and adverse events and safety investigations
  • Establish complaint triggers and analyze trends looking across products and delivery systems
  • Direct interaction with health and regulatory authorities during inspections, speaking on behalf of Amgen
  • Responsible to provide oversight of training and ensure continued effectiveness for call center staff
  • Manages self-audit program for Complaints
  • Communicates issues and action plans to management and as part of Management Review and Annual Product Reviews (APR), leveraging appropriate quality management systems to escalate accordingly
  • Ensures appropriate identification of critical events and escalation per business process
  • Contributes to inspection readiness activities
  • Leads cross-functional initiatives


Basic Qualifications:
  • Doctorate degree & 6 years of Quality experience OR
  • Master's degree & 10 years of Quality experience OR
  • Bachelor's degree & 12 years of Quality experience AND
  • 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources


Preferred Qualifications:
  • Advanced degree in Biology, Pharmaceutics, Biotechnology, Engineering, Physics or related discipline
  • 15+ years of experience within the pharmaceutical/biotechnology industry
  • Deep and broad understanding of Quality including batch release, complaints, change control, risk management, etc
  • Problem solving, trouble shooting, and communication skills
  • Experience with leadership in various quality functions
  • Ability to remain calm under duress or in stressful situations
  • Ability to understand details, and also flex to understand and communicate strategic intent
  • Ability to articulate issues to executive leadership
  • Experience creating an environment that promotes growth (develops leaders) and provides the tools to develop the next generation of leaders
  • Makes risk-based decisions based on Amgen First and decision-making processes that reflect Quality beyond compliance
  • Fosters continuous improvement by challenging status quo
  • Direct experience leading complex investigations and serving as a primary point of contact representing the organization with external agencies
  • Experience leading a global team, to include managing the team through significant change
  • Ability to work effectively in global cross-functional teams and in a matrix team environment
  • Drive change, efficiency, and cross-functionality
  • Up to 25% Domestic and international travel may be required


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.

PI115347591

<b>Amgen</b><br/><br/><b>Job ID: </b>R-87655<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/><b>Executive Director Quality, Product Complaints and Surveillance</b><br><br>The Executive Director Quality is responsible for leading the strategy and execution of Quality oversight for the global complaint business process and management system at Amgen. This role will report to the Vice President, Final Product Quality and Surveillance and assures complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. The position Interfaces directly with agencies during inspections and provides response to agency requests regarding the complaints process and leads the team through the development of requirements and ensures procedures are in place for the complaint management system. He/She will work closely with global regulatory and safety leadership to assure complaints business process is adapted to emerging trends or new requirements in regulations while working in close partnership with internal Amgen leadership and executive management beyond Operations to ensure successful issues resolution and continuous improvement. He/She will alert and advise executive management on significant Quality, compliance, supply and safety risks and provide authoritative advice to top management based on deep subject matter expertise in Quality while being accountable to develop and lead a global team that provides Quality oversight and is responsible for the management of product complaints. He/She will ensure that there is an adequate number of qualified personnel who possess a combination of education, experience and training to perform the work in accordance with requirements and specifications.<br><br><b>Key Responsibilities</b><br><ul><li>Oversight of global complaints business process management and continuous improvement, including setting the global strategy for complaints management</li><li>Maintains oversight of complaints throughout the life cycle from intake, processing, and through closure</li><li>Assure proper program design is used to assign site assessments for complaints</li><li>Applies in-depth knowledge and subject matter expertise to determine the steps necessary to advance the quality system in order to address complaint causes</li><li>Provides accurate and robust surveillance information that meets global health authorities and Amgen requirements</li><li>Leverages expertise and effectively engages with technical functions to translate risk assessments into complaint codes and decision trees and ensure continual alignment with regulatory filings</li><li>Oversight of internal lab operations for investigations of return complaint samples</li><li>Manage data sources used for trending, provide necessary data to technical teams for advanced analysis</li><li>Ensure there is alignment between linked product complaint and adverse events and safety investigations</li><li>Establish complaint triggers and analyze trends looking across products and delivery systems</li><li>Direct interaction with health and regulatory authorities during inspections, speaking on behalf of Amgen</li><li>Responsible to provide oversight of training and ensure continued effectiveness for call center staff</li><li>Manages self-audit program for Complaints</li><li>Communicates issues and action plans to management and as part of Management Review and Annual Product Reviews (APR), leveraging appropriate quality management systems to escalate accordingly</li><li>Ensures appropriate identification of critical events and escalation per business process</li><li>Contributes to inspection readiness activities</li><li>Leads cross-functional initiatives</li></ul><br><br><b>Basic Qualifications</b>:<br><ul><li>Doctorate degree & 6 years of Quality experience OR</li><li>Master's degree & 10 years of Quality experience OR</li><li>Bachelor's degree & 12 years of Quality experience AND</li><li>6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources</li></ul><br><br><b>Preferred Qualifications</b>:<br><ul><li>Advanced degree in Biology, Pharmaceutics, Biotechnology, Engineering, Physics or related discipline</li><li>15+ years of experience within the pharmaceutical/biotechnology industry</li><li>Deep and broad understanding of Quality including batch release, complaints, change control, risk management, etc</li><li>Problem solving, trouble shooting, and communication skills</li><li>Experience with leadership in various quality functions</li><li>Ability to remain calm under duress or in stressful situations</li><li>Ability to understand details, and also flex to understand and communicate strategic intent</li><li>Ability to articulate issues to executive leadership</li><li>Experience creating an environment that promotes growth (develops leaders) and provides the tools to develop the next generation of leaders</li><li>Makes risk-based decisions based on Amgen First and decision-making processes that reflect Quality beyond compliance</li><li>Fosters continuous improvement by challenging status quo</li><li>Direct experience leading complex investigations and serving as a primary point of contact representing the organization with external agencies</li><li>Experience leading a global team, to include managing the team through significant change</li><li>Ability to work effectively in global cross-functional teams and in a matrix team environment</li><li>Drive change, efficiency, and cross-functionality</li><li>Up to 25% Domestic and international travel may be required</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/yg78AZhbGeVPhkAdFGNVO"> <p>PI115347591</p>

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Posted: 2019-11-09 Expires: 2019-12-10

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Executive Director Quality, Product Complaints and Surveillance

Amgen
Thousand Oaks, CA 91360

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