18 days old

Senior Quality Complaints Professional

Amgen
Thousand Oaks, CA 91360
  • Job Code
    114997537
Amgen

Job ID: R-86032
Location: Thousand Oaks, CA, US 91360
Additional Location: US - Puerto Rico - Juncos, Ireland - Dublin, US - Rhode Island - West Greenwich, US - Massachusetts - Cambridge, US - Florida - Tampa, Netherlands - Breda

The Senior Quality Complaints Professional is accountable to determine regulatory requirements for Complaint Intake and any action which may be necessary to show due diligence with Complaint Intake. This role may oversee a group of Complaint Investigators/Managers which drive compliant documentation of customer complaints for products produced by external suppliers.

Key Responsibilities
  • Applies in-depth knowledge and subject matter expertise to determine the steps necessary to advance the complaint intake
  • Leads cross-functional teams in analysis of the situation and the necessary steps
  • Provides dedicated audit and inspection readiness and support
  • Conducts analyses related to inquiries from health authorities and summarizes key findings, driving to resolution
  • Conducts complex root cause analysis of product complaint intake issues and provides insights on the appropriate manner to prevent them in the future
  • Interprets SOP and regulatory requirements
  • Sets project timelines and priorities
  • Authoring and maintaining probing questions in partnership with Med-Communications, Amgen Safety, and Final Product Technologies (FPT)
  • Provides Quality oversight and management of U.S. and Written Intake call centers; ensure purchasing controls are met and followed
  • Drafting and conducting quality monitoring of call centers to ensure compliance with internal and regulatory requirements
  • Develops and maintains product complaint training for complaint intake staff
  • Drives Operational Excellence and Champions Change
  • Responsible for Business Continuity Plans for Complaints Intake Processes
  • Represents Amgen to regulatory authorities
  • Advises Amgen teams on issues surrounding complaints intake during investigations and inspections
  • Complaint triage (complaint classification and codes)
  • May establish performance expectations and lead team development
  • Ensures training is continuously maintained, audits performance and records of staff to assure compliance with policy and procedure
  • Accountable for daily operations of staff members under their supervision
  • Financial oversight / team's budget management


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 and 12 years of Quality experience

Preferred Qualifications :
  • 8+ years of quality and manufacturing experience in biotech or pharmaceutical industry
  • Bachelor's 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 position after taking feedback from multiple sources
  • Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality results
  • Ability to operate in a matrixed or team environment with site, functional, and executive leadership
  • Experience in driving decision making
  • Knowledge of industry regulations and their applicability
  • Six sigma certification and/or working knowledge
  • Understanding of industry requirements/expectations of a Quality Management System (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.

PI114997537

<b>Amgen</b><br/><br/><b>Job ID: </b>R-86032<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><b>Additional Location: </b>US - Puerto Rico - Juncos, Ireland - Dublin, US - Rhode Island - West Greenwich, US - Massachusetts - Cambridge, US - Florida - Tampa, Netherlands - Breda<br/><br/>The Senior Quality Complaints Professional is accountable to determine regulatory requirements for Complaint Intake and any action which may be necessary to show due diligence with Complaint Intake. This role may oversee a group of Complaint Investigators/Managers which drive compliant documentation of customer complaints for products produced by external suppliers.<br><br><b> Key Responsibilities </b><br><ul><li>Applies in-depth knowledge and subject matter expertise to determine the steps necessary to advance the complaint intake</li><li>Leads cross-functional teams in analysis of the situation and the necessary steps </li><li>Provides dedicated audit and inspection readiness and support</li><li>Conducts analyses related to inquiries from health authorities and summarizes key findings, driving to resolution</li><li>Conducts complex root cause analysis of product complaint intake issues and provides insights on the appropriate manner to prevent them in the future</li><li>Interprets SOP and regulatory requirements</li><li>Sets project timelines and priorities</li><li>Authoring and maintaining probing questions in partnership with Med-Communications, Amgen Safety, and Final Product Technologies (FPT)</li><li>Provides Quality oversight and management of U.S. and Written Intake call centers; ensure purchasing controls are met and followed</li><li>Drafting and conducting quality monitoring of call centers to ensure compliance with internal and regulatory requirements</li><li>Develops and maintains product complaint training for complaint intake staff</li><li>Drives Operational Excellence and Champions Change</li><li>Responsible for Business Continuity Plans for Complaints Intake Processes</li><li>Represents Amgen to regulatory authorities</li><li>Advises Amgen teams on issues surrounding complaints intake during investigations and inspections</li><li>Complaint triage (complaint classification and codes)</li><li>May establish performance expectations and lead team development</li><li>Ensures training is continuously maintained, audits performance and records of staff to assure compliance with policy and procedure</li><li>Accountable for daily operations of staff members under their supervision</li><li>Financial oversight / team's budget management</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 and 12 years of Quality experience <br><br><b> Preferred Qualifications </b>:<br><ul><li>8+ years of quality and manufacturing experience in biotech or pharmaceutical industry</li><li>Bachelor's 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 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>Ability to operate in a matrixed or team environment with site, functional, and executive leadership</li><li>Experience in driving decision making</li><li>Knowledge of industry regulations and their applicability</li><li>Six sigma certification and/or working knowledge</li><li>Understanding of industry requirements/expectations of a Quality Management System (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/dappKmfYgRLDTJzgi1Pmz"> <p>PI114997537</p>

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Posted: 2019-10-31 Expires: 2019-12-01

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Senior Quality Complaints Professional

Amgen
Thousand Oaks, CA 91360

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