16 days old

Director Product Complaints & Surveillance

Amgen
Cambridge, MA 02138
  • Job Code
    117985294
Amgen

Job ID: R-93413
Location: Cambridge, MA, US 02139

Job Summary

Amgen is seeking a Director Product Complaints and Surveillance reporting directly to the Executive Director, Product Complaints and Surveillance. The Product Complaints and Surveillance team owns and executes the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement.

The Director leads a global quality complaints team, maintaining accountability for day to day operations of the team. Assures complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. Works with key internal stakeholders to enable issues resolution and continuous improvement. Interfaces directly with agencies during inspections and provides response to agency requests regarding the complaints process. Sets requirements and procedures in place for the complaint management system. Works closely with global regulatory and safety to assure complaints business process is adapted to emerging trends or new requirements in regulations. Ensures 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:
  • Drives execution of the global complaints business process and continuous improvement
  • Maintains oversight of complaints throughout the lifecycle from intake, processing, and through closure
  • Assures proper program design 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 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
  • Manages data sources used for trending, provide necessary data to technical teams for advanced analysis
  • Ensures alignment between linked product complaint and adverse events investigations with Safety
  • Establishes complaint triggers and analyzes trends looking across products and delivery systems
  • Direct interaction with health and regulatory authorities during inspections, speaking on behalf of Amgen
  • Manages self-audit program for Complaints (Right First Time)
  • Communicates risks to the business
  • Communicates issues and action plans to management, leveraging appropriate quality management systems to escalate accordingly
  • Ensures appropriate identification of critical events and escalation per business process
  • Escalates critical issues and findings to ensure incorporation into Management Review
  • Ensures continuous feedback loop to complaint intake process specifically in the area of probing questions
  • Contributes to inspection readiness activities
  • Leads cross-functional initiatives
  • Interprets SOPs and regulatory requirements
  • Sets project timelines and priorities for key initiatives and/or team activities
  • Provides guidance and technical advice to key stakeholders
  • Leads and develops a team, providing staff member supervision and on-going coaching
  • Drives Operational Excellence and champions change
  • Strategically plans, analyzes, and manages resources to include budget, contractors, staff, etc.


Basic Qualifications

Doctorate degree and 4 years of Quality experience

OR

Master's degree and 8 years of Quality experience

OR

Bachelor's degree and 10 years of Quality 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 of quality and manufacturing experience in biotech or pharmaceutical industry
  • Advanced Degree in a Science Field
  • Combination products expertise
  • Leadership skills and the ability to oversee multiple projects simultaneously
  • Able to successfully manage workload to timelines
  • Able to respond and provide astute advice quickly to difficult scenarios or in response to tough questions
  • Familiarity with basic project management tools
  • Ability to negotiate a strategic position after taking feedback from multiple sources
  • Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and with high-quality results
  • Strong aptitude for coaching and providing on-going mentoring and guidance to team
  • Ability to operate in a matrixed or team environment with site, functional, and executive leadership
  • Experience driving decision making by using DAI principles
  • Relevant experience having led a complaints organization
  • Experience leading and coaching a diverse, globally dispersed team
  • Highly skilled at interacting effectively with inspectors and agency regulators
  • Working knowledge of applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device Manufacturing, Design Controls)
  • Ability to succinctly communicate level of risk, urgency, or impact to the business
  • Practical knowledge of human factors principles and best practices
  • Practical knowledge of risk assessments and their application to complaints investigation
  • Ability to travel +/- 20% of time to domestic and international Amgen sites


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.

PI117985294

<b>Amgen</b><br/><br/><b>Job ID: </b>R-93413<br/><b>Location: </b>Cambridge, MA, US 02139<br/><br/><b>Job Summary</b><br><br>Amgen is seeking a Director Product Complaints and Surveillance reporting directly to the Executive Director, Product Complaints and Surveillance. The Product Complaints and Surveillance team owns and executes the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement.<br><br>The Director leads a global quality complaints team, maintaining accountability for day to day operations of the team. Assures complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. Works with key internal stakeholders to enable issues resolution and continuous improvement. Interfaces directly with agencies during inspections and provides response to agency requests regarding the complaints process. Sets requirements and procedures in place for the complaint management system. Works closely with global regulatory and safety to assure complaints business process is adapted to emerging trends or new requirements in regulations. Ensures 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> Drives execution of the global complaints business process and continuous improvement </li><li> Maintains oversight of complaints throughout the lifecycle from intake, processing, and through closure </li><li> Assures proper program design 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 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> Manages data sources used for trending, provide necessary data to technical teams for advanced analysis </li><li> Ensures alignment between linked product complaint and adverse events investigations with Safety </li><li> Establishes complaint triggers and analyzes 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> Manages self-audit program for Complaints (Right First Time) </li><li> Communicates risks to the business </li><li> Communicates issues and action plans to management, leveraging appropriate quality management systems to escalate accordingly </li><li> Ensures appropriate identification of critical events and escalation per business process </li><li> Escalates critical issues and findings to ensure incorporation into Management Review </li><li> Ensures continuous feedback loop to complaint intake process specifically in the area of probing questions </li><li> Contributes to inspection readiness activities </li><li> Leads cross-functional initiatives </li><li> Interprets SOPs and regulatory requirements </li><li> Sets project timelines and priorities for key initiatives and/or team activities </li><li> Provides guidance and technical advice to key stakeholders </li><li> Leads and develops a team, providing staff member supervision and on-going coaching </li><li> Drives Operational Excellence and champions change </li><li> Strategically plans, analyzes, and manages resources to include budget, contractors, staff, etc. </li></ul><br><br><b>Basic Qualifications </b><br><br>Doctorate degree and 4 years of Quality experience<br><br>OR<br><br>Master's degree and 8 years of Quality experience<br><br>OR<br><br>Bachelor's degree and 10 years of Quality 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>10+ years of quality and manufacturing experience in biotech or pharmaceutical industry</li><li>Advanced Degree in a Science Field</li><li>Combination products expertise</li><li>Leadership skills and the ability to oversee multiple projects simultaneously</li><li>Able to successfully manage workload to timelines</li><li>Able to respond and provide astute advice quickly to difficult scenarios or in response to tough questions</li><li>Familiarity with basic project management tools</li><li>Ability to negotiate a strategic position after taking feedback from multiple sources</li><li>Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and with high-quality results</li><li>Strong aptitude for coaching and providing on-going mentoring and guidance to team</li><li>Ability to operate in a matrixed or team environment with site, functional, and executive leadership</li><li>Experience driving decision making by using DAI principles</li><li>Relevant experience having led a complaints organization</li><li>Experience leading and coaching a diverse, globally dispersed team</li><li>Highly skilled at interacting effectively with inspectors and agency regulators</li><li>Working knowledge of applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device Manufacturing, Design Controls)</li><li>Ability to succinctly communicate level of risk, urgency, or impact to the business</li><li>Practical knowledge of human factors principles and best practices</li><li>Practical knowledge of risk assessments and their application to complaints investigation</li><li>Ability to travel +/- 20% of time to domestic and international Amgen sites</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/2VlbLLfWzZr4IZVPFDBKj"> <p>PI117985294</p>

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Posted: 2020-02-12 Expires: 2020-03-14

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Director Product Complaints & Surveillance

Amgen
Cambridge, MA 02138

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