4 days old

Specialist Quality Compliance

Amgen
Thousand Oaks, CA 91360
  • Job Code
    116016629
Amgen

Job ID: R-88639
Location: Thousand Oaks, CA, US 91360

This position will support the Quality Systems department with Audit and Inspection management. The Quality Systems team supports the site with Electronic Systems, Validation, Management Review, Deviation Management, Change Control Management, Document Management and Audits/Inspections.

The Specialist Quality Compliance will act as the Site Process Owner and Subject Matter Expert for site Internal Audits, Partner Audits and Regulatory Inspections (Audit and Inspection Program).

Responsibilities Include:
  • Developing and implementing a cross functional inspection management infrastructure from preparation/planning through execution and performing key leadership roles within the inspection management team
  • Recruiting and training the inspection/audit management teams
  • Developing and maintaining a comprehensive inspection readiness program, sustainable for increasing inspections from Research & Development, through pre-pivotal and Commercial operations across a wide range of regulatory authorities and product modalities
  • Integrating cross-functional stakeholder organizations into the inspection readiness infrastructure
  • Managing post audit/inspection response writing, review, approval and submission to Amgen Partners and Regulatory Authorities ensuring any impact to the operation is understood and taken into consideration in relation to the criticality of the findings
  • Ensuring adequate integration of regulatory commitments into the appropriate Quality Management System processes to sustain commitment adherence
  • Compiling and maintaining evidence-based documents for subsequent verification of prior regulatory commitments
  • Developing a risk-based internal audit schedule intended to focus on areas of high risk, drive appropriate mitigations, reduce risk to patient safety and maintain a positive regulatory reputation
  • Executing site internal audits in the role of lead auditor for multiple audits across Thousand Oaks site, and Corporate Operations, ensuring that regulatory requirements and expectations are adequately interpreted and appropriately implemented across all phases of the product life cycle
  • Training, mentoring and qualifying new auditors across the Audits and Inspections Global Network
  • Development of the site internal audit program strategy in a manner designed to improve audit efficiency and staff capabilities


Basic Qualifications

Doctorate degree

OR

Master's degree and 3 years of Quality experience

OR

Bachelor's degree and 5 years of Quality experience

OR

Associates degree and 10 years of Quality experience

OR

High school diploma / GED and 12 years of Quality experience

Preferred Qualifications
  • Excellent interpersonal skills
  • Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners
  • Strong skills in data analysis skills and business case development
  • Direct experience driving process improvements. Working knowledge of Lean and Six Sigma methodologies a plus
  • Experience with cGMP production environments. Direct work experience with cGMP processes involved in manufacturing and distribution, QA, analytical laboratory, validation, and process development a plus
  • Experience participating in, managing, and responding to corporate audits/regulatory inspections
  • Experience with TrackWise for supporting investigations and CAPA
  • Experience with Quality Management Systems, including Change Control, Risk Management, Disposition
  • Demonstrated ability with project management, initiating and leading cross-functional teams, leading and managing change
  • Biology, Chemistry, or Engineering degree is desirable


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.

PI116016629

<b>Amgen</b><br/><br/><b>Job ID: </b>R-88639<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>This position will support the Quality Systems department with Audit and Inspection management. The Quality Systems team supports the site with Electronic Systems, Validation, Management Review, Deviation Management, Change Control Management, Document Management and Audits/Inspections.<br><br>The Specialist Quality Compliance will act as the Site Process Owner and Subject Matter Expert for site Internal Audits, Partner Audits and Regulatory Inspections (Audit and Inspection Program).<br><br><b>Responsibilities Include:</b><br><ul><li>Developing and implementing a cross functional inspection management infrastructure from preparation/planning through execution and performing key leadership roles within the inspection management team</li><li>Recruiting and training the inspection/audit management teams</li><li>Developing and maintaining a comprehensive inspection readiness program, sustainable for increasing inspections from Research & Development, through pre-pivotal and Commercial operations across a wide range of regulatory authorities and product modalities</li><li>Integrating cross-functional stakeholder organizations into the inspection readiness infrastructure</li><li>Managing post audit/inspection response writing, review, approval and submission to Amgen Partners and Regulatory Authorities ensuring any impact to the operation is understood and taken into consideration in relation to the criticality of the findings</li><li>Ensuring adequate integration of regulatory commitments into the appropriate Quality Management System processes to sustain commitment adherence</li><li>Compiling and maintaining evidence-based documents for subsequent verification of prior regulatory commitments</li><li>Developing a risk-based internal audit schedule intended to focus on areas of high risk, drive appropriate mitigations, reduce risk to patient safety and maintain a positive regulatory reputation</li><li>Executing site internal audits in the role of lead auditor for multiple audits across Thousand Oaks site, and Corporate Operations, ensuring that regulatory requirements and expectations are adequately interpreted and appropriately implemented across all phases of the product life cycle</li><li>Training, mentoring and qualifying new auditors across the Audits and Inspections Global Network</li><li>Development of the site internal audit program strategy in a manner designed to improve audit efficiency and staff capabilities</li></ul><br><br><b> Basic Qualifications </b><br><br>Doctorate degree<br><br>OR<br><br>Master's degree and 3 years of Quality experience<br><br>OR<br><br>Bachelor's degree and 5 years of Quality experience<br><br>OR<br><br>Associates 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>Excellent interpersonal skills</li><li>Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners</li><li>Strong skills in data analysis skills and business case development</li><li>Direct experience driving process improvements. Working knowledge of Lean and Six Sigma methodologies a plus</li><li>Experience with cGMP production environments. Direct work experience with cGMP processes involved in manufacturing and distribution, QA, analytical laboratory, validation, and process development a plus</li><li>Experience participating in, managing, and responding to corporate audits/regulatory inspections</li><li>Experience with TrackWise for supporting investigations and CAPA</li><li>Experience with Quality Management Systems, including Change Control, Risk Management, Disposition</li><li>Demonstrated ability with project management, initiating and leading cross-functional teams, leading and managing change</li><li>Biology, Chemistry, or Engineering degree is desirable</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/8OmPqAu4lllNfEVNhwkaB"> <p>PI116016629</p>

Categories

Posted: 2019-12-03 Expires: 2020-01-03

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Specialist Quality Compliance

Amgen
Thousand Oaks, CA 91360

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast