13 days old

Sr. Manager Quality Complaints

Amgen
Juncos, Puerto Rico 00777
  • Job Code
    119286614
Amgen

Job ID: R-96802
Location: Juncos, PR, US 00777

Job Summary:

Amgen is seeking a Sr. Manager Quality Complaints. This role will report to the Director, Quality Complaints. 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 quality complaints team responsible for driving compliant documentation of customer complaints for Amgen products. 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. 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:
  • Establishes performance expectations and monitors for daily improvement, assures training is continuously maintained, audits performance and records of staff to assure compliance with policy and procedure
  • Accountable for day to day operations of the staff members under their supervision
  • Provides direct feedback to team to ensure daily improvement through purposeful presence
  • Owns and maintains workforce models, training plans, and staff recruiting onboarding and offboarding
  • Leads team's performance and oversight of staff's performance and development
  • Takes an active leadership role as part of the product complaints organization, supporting the defined strategy and work towards reaching identified goals
  • Drives a culture of continuous improvement within the complaints function
  • Leads strategy development and establishes business cases for annual or initiative budgets
  • Responsible for financial oversight / team's budget management
  • Serves as subject matter expert in complaint processing and understanding of global regulatory requirements
  • Identifies and addresses challenges impacting staff's ability to adequately evaluate product complaints within a standardized process
  • Leads cross-functional initiatives
  • Ensures execution of regulatory and SOP requirements
  • Prioritizes, sets goals and performance targets, project timelines and priorities
  • Provides guidance and technical advice
  • Leads and develops a team, providing direct staff member supervision and on-going coaching
  • Drives Operational Excellence and champions change


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

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
  • Leadership skills and the ability to oversee multiple projects simultaneously
  • Ability to successfully manage workload to timelines
  • 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 high-quality results
  • Aptitude for coaching and providing on-going mentoring and guidance to team
  • Experience interacting effectively with inspectors and agency regulators
  • Ability to operate in a matrixed or team environment with site, functional, and executive leadership
  • Experience in driving decision making by using appropriate principles (e.g., Amgen DAI)
  • Understanding of industry requirements/expectations of a QMS
  • Understanding of the applicable manufacturing/testing processes (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
  • 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.

PI119286614

<b>Amgen</b><br/><br/><b>Job ID: </b>R-96802<br/><b>Location: </b>Juncos, PR, US 00777<br/><br/><b>Job Summary:</b><br><br>Amgen is seeking a Sr. Manager Quality Complaints. This role will report to the Director, Quality Complaints. 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 quality complaints team responsible for driving compliant documentation of customer complaints for Amgen products. 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. 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> Establishes performance expectations and monitors for daily improvement, assures training is continuously maintained, audits performance and records of staff to assure compliance with policy and procedure </li><li> Accountable for day to day operations of the staff members under their supervision </li><li> Provides direct feedback to team to ensure daily improvement through purposeful presence </li><li> Owns and maintains workforce models, training plans, and staff recruiting onboarding and offboarding </li><li> Leads team's performance and oversight of staff's performance and development </li><li> Takes an active leadership role as part of the product complaints organization, supporting the defined strategy and work towards reaching identified goals </li><li> Drives a culture of continuous improvement 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> Serves as subject matter expert in complaint processing and understanding of global regulatory requirements </li><li> Identifies and addresses challenges impacting staff's ability to adequately evaluate product complaints within a standardized process </li><li> Leads cross-functional initiatives </li><li> Ensures execution of regulatory and SOP requirements </li><li> Prioritizes, sets goals and performance targets, project timelines and priorities </li><li> Provides guidance and technical advice </li><li> Leads and develops a team, providing direct staff member supervision and on-going coaching </li><li> Drives Operational Excellence and champions change </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>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>Leadership skills and the ability to oversee multiple projects simultaneously</li><li>Ability to successfully manage workload to timelines</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 high-quality results</li><li>Aptitude for coaching and providing on-going mentoring and guidance to team</li><li>Experience interacting effectively with inspectors and agency regulators</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 appropriate principles (e.g., Amgen DAI)</li><li>Understanding of industry requirements/expectations of a QMS</li><li>Understanding of the applicable manufacturing/testing processes (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)</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/V7WMdbUMmg5BI658uORqV"> <p>PI119286614</p>

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Posted: 2020-03-24 Expires: 2020-04-24

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Sr. Manager Quality Complaints

Amgen
Juncos, Puerto Rico 00777

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