15 days old

Sr. Manager Complaints Investigations Oversight

Amgen
Thousand Oaks, CA 91360
  • Job Code
    117985275
Amgen

Job ID: R-93414
Location: Thousand Oaks, CA, US 91360
Additional Location: US - Puerto Rico - Juncos, US - Massachusetts - Cambridge

Job Summary

Amgen is seeking a Sr. Manager Quality Complaints Investigations Oversight. This role will report 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 Sr. Manager leads a team of highly skilled quality investigators responsible for end-to-end management of investigations associated with complaints for Amgen products. Drives compliance and ensures consistency of major complaint investigations. Works with key stakeholders across Amgen to enable issues resolution and continuous improvement. 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:
  • Manages a team that provides end-to-end oversight of major complaint investigations with high impact (e.g., level 2 and 3 complaint investigations, quality defect investigations, trend and consolidated investigations)
  • Leads the team in developing responses to major investigations and determining appropriate corrective and preventive actions (CAPA)
  • Represents Quality on Deviation Review Team (DRT)
  • Ensures that the investigations reach an appropriate root cause conclusion and that mistake-proof CAPAs are identified and initiated
  • Manages deviations related to a Known Quality Defect, ensuring related complaints are investigated and documented per procedures
  • Maintains an inspection ready status for all the investigations managed by the team
  • Ensures direct reports are qualified and trained to perform assigned functions in accordance with cGMP with requirements
  • Takes an active leadership role as part of the product complaints organization, supporting the defined strategy and working towards reaching identified goals
  • Ensures the Quality Management System is followed, maintained and reviewed in accordance with cGMP regulations
  • Alerts senior management of significant quality, compliance, supply and safety risks
  • Audits performance and records of staff to assure compliance with policy and procedure
  • Owns and maintains workforce models, training plans, and staff recruiting onboarding and offboarding
  • Drives a culture of continuous improvement and Operational Excellence within the complaints function
  • Leads strategy development and establishes business cases for annual or initiative budgets
  • Responsible for financial oversight / team's budget management
  • Supports and identifies continual improvement initiatives, programs and projects
  • Leads cross-functional initiatives
  • Ensures execution of regulatory and SOP requirements
  • Provides guidance and technical advice
  • Leads and develops a team, providing direct staff member supervision and on-going coaching


Basic Qualifications

Doctorate degree and 2 years of Quality experience

OR

Master's degree and 6 years of Quality experience

OR

Bachelor's degree and 8 years of Quality experience

OR

Associate's degree and 10 years of Quality experience

OR

High school diploma / GED & 12 years of Quality experience

AND

2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications
  • 8+ years of quality and manufacturing experience in biotech or pharmaceutical industry
  • Advanced Degree in a Science Field
  • Expertise in Root Cause Analysis (RCA) process and ability to transfer that knowledge to other staff
  • Expertise in development management and complex investigations
  • Combination products expertise
  • Demonstrated ability to deep dive into technical issues and also appropriately manage upward
  • Ability to successfully manage workload to timelines
  • Ability to negotiate a strategic position after taking feedback from multiple sources
  • Leadership skills and the ability to oversee multiple projects simultaneously
  • Demonstrated ability to manage a team of high level / highly skilled individual contributors
  • Ability to delegate wisely and effectively
  • Works effectively with diverse departmental groups
  • Ability to operate in a matrixed or team environment with site, functional, and executive leadership
  • Experience in driving decision making by using DAI principles and risk matrix
  • Excellent team development and leadership skills
  • Skill and knowledge of and experience with processes involved in manufacturing and distribution, QA, Quality Control, validation, and process development
  • Experience interacting effectively with inspectors and agency regulators
  • Commands respect from team, peers, and management
  • Excellent presentation skills to all audiences
  • Thorough knowledge of CFRs, GMPs and pharmaceutical processing and demonstrated ability to apply them
  • Able to make sound, quality decisions independently
  • Excellent communication and executive presence (both written and verbal), facilitation, and presentation skills
  • Skilled in risk management
  • 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.

PI117985275

<b>Amgen</b><br/><br/><b>Job ID: </b>R-93414<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><b>Additional Location: </b>US - Puerto Rico - Juncos, US - Massachusetts - Cambridge<br/><br/><b>Job Summary</b><br><br>Amgen is seeking a Sr. Manager Quality Complaints Investigations Oversight. This role will report 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 Sr. Manager leads a team of highly skilled quality investigators responsible for end-to-end management of investigations associated with complaints for Amgen products. Drives compliance and ensures consistency of major complaint investigations. Works with key stakeholders across Amgen to enable issues resolution and continuous improvement. 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> Manages a team that provides end-to-end oversight of major complaint investigations with high impact (e.g., level 2 and 3 complaint investigations, quality defect investigations, trend and consolidated investigations) </li><li> Leads the team in developing responses to major investigations and determining appropriate corrective and preventive actions (CAPA) </li><li> Represents Quality on Deviation Review Team (DRT) </li><li> Ensures that the investigations reach an appropriate root cause conclusion and that mistake-proof CAPAs are identified and initiated </li><li> Manages deviations related to a Known Quality Defect, ensuring related complaints are investigated and documented per procedures </li><li> Maintains an inspection ready status for all the investigations managed by the team </li><li> Ensures direct reports are qualified and trained to perform assigned functions in accordance with cGMP with requirements </li><li> Takes an active leadership role as part of the product complaints organization, supporting the defined strategy and working towards reaching identified goals </li><li> Ensures the Quality Management System is followed, maintained and reviewed in accordance with cGMP regulations </li><li> Alerts senior management of significant quality, compliance, supply and safety risks </li><li> Audits performance and records of staff to assure compliance with policy and procedure </li><li> Owns and maintains workforce models, training plans, and staff recruiting onboarding and offboarding </li><li> Drives a culture of continuous improvement and Operational Excellence within the complaints function </li><li> Leads strategy development and establishes business cases for annual or initiative budgets </li><li> Responsible for financial oversight / team's budget management </li><li> Supports and identifies continual improvement initiatives, programs and projects </li><li> Leads cross-functional initiatives </li><li> Ensures execution of regulatory and SOP requirements </li><li> Provides guidance and technical advice </li><li> Leads and develops a team, providing direct staff member supervision and on-going coaching </li></ul><br><br><b>Basic Qualifications </b><br><br>Doctorate degree and 2 years of Quality experience<br><br>OR<br><br>Master's degree and 6 years of Quality experience<br><br>OR<br><br>Bachelor's degree and 8 years of Quality experience<br><br>OR<br><br>Associate's degree and 10 years of Quality experience<br><br>OR<br><br>High school diploma / GED & 12 years of Quality experience<br><br>AND<br><br>2 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>8+ years of quality and manufacturing experience in biotech or pharmaceutical industry</li><li>Advanced Degree in a Science Field</li><li>Expertise in Root Cause Analysis (RCA) process and ability to transfer that knowledge to other staff</li><li>Expertise in development management and complex investigations</li><li>Combination products expertise</li><li>Demonstrated ability to deep dive into technical issues and also appropriately manage upward</li><li>Ability to successfully manage workload to timelines</li><li>Ability to negotiate a strategic position after taking feedback from multiple sources</li><li>Leadership skills and the ability to oversee multiple projects simultaneously</li><li>Demonstrated ability to manage a team of high level / highly skilled individual contributors</li><li>Ability to delegate wisely and effectively</li><li>Works effectively with diverse departmental groups</li><li>Ability to operate in a matrixed or team environment with site, functional, and executive leadership</li><li>Experience in driving decision making by using DAI principles and risk matrix</li><li>Excellent team development and leadership skills</li><li>Skill and knowledge of and experience with processes involved in manufacturing and distribution, QA, Quality Control, validation, and process development</li><li>Experience interacting effectively with inspectors and agency regulators</li><li>Commands respect from team, peers, and management</li><li>Excellent presentation skills to all audiences</li><li>Thorough knowledge of CFRs, GMPs and pharmaceutical processing and demonstrated ability to apply them</li><li>Able to make sound, quality decisions independently</li><li>Excellent communication and executive presence (both written and verbal), facilitation, and presentation skills</li><li>Skilled in risk management</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/ljV7BRTpn8wWibo4uJArQ"> <p>PI117985275</p>

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

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Sr. Manager Complaints Investigations Oversight

Amgen
Thousand Oaks, CA 91360

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