14 days old

Senior Manager Quality Compliance

Amgen
Thousand Oaks, CA 91360
  • Job Code
    116956992
Amgen

Job ID: R-89288
Location: Thousand Oaks, CA, US 91360

The Senior Manager Quality Compliance will report directly to the Amgen Thousand Oaks (ATO) Quality Site Head and provide management and oversight for the following areas: ATO Internal Audit Program, QMS Compliance and Site Master File (SMF), Commitment Management, Regulatory certifications and declarations, Audit and Inspection Management, and GxP Intelligence coordination and management.

Job Responsibilities:

Internal Compliance:

ATO Internal Audit Program:
  • Accountable for the establishment of a risk-based Master Audit Schedule (MAS)
  • Ensures internal audits are performed and completed per the approved MAS


QMS Compliance Oversight:
  • Responsible for the following reviews and evaluations: Biological Product Deviation Reports (BPDRs), Annual Product Reviews (APR), Complaint Reportability Evaluations, Recalls and Stock Recoveries, Procedure Reviews
  • Management Review: Compiles and reports Quality Compliance Metrics
  • Owns and manages the Site Master File per approved procedures to ensure accuracy and adherence to applicable regulations


Commitment Management:
  • Ensures integration of commitments into the appropriate QMS process and on-time commitment closure
  • Evaluates commitment applicability
  • Ensures life-cycle management of commitments
  • Collaborates with Regulatory Affairs to approve Quality & Regulatory Licenses and Certificates/Declarations

QMS Continuous Improvements:
  • Represents the ATO site on the Audits and Inspection Network (AIN) and Compliance Forum


Inspection (including External Audit, Document Inspection and Experiential Visit) Management:

Responsible for implementing and sustaining the site Inspection Readiness Program plan with visible and measurable outputs. Performing tasks including but not limited to:
  • Identification, tracking and reporting of top compliance concerns
  • Leading/participating in strategy and pressure test sessions
  • Verification of sustained commitment compliance
  • Maintaining a cross functional-trained resource pool for inspection management roles
  • Responsible for inspection planning, execution and post process management, including but not limited to:
    • Coordination of inspection logistics
    • Oversight of inspection process execution
    • Serve as inspection lead and/or inspection escort
    • Own, lead and manage the post inspection process for response drafting, review, approval, submission and the global applicability process


GxP Intelligence & Regulatory Commenting :
  • Site representative for the triage, coordination, management and execution of reviews for global draft applicable regulations, in collaboration with other impacted organizations.


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

Associated degree and 10 years of Quality experience

OR

High school diploma / GED and 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:
  • Broad knowledge of global regulatory compliance, global regulators and audits/inspections
  • Experience hosting or participating in regulatory inspections
  • Detail-oriented with experience in QA/QC functions across a broad range of manufacturing, QC and/or supply chain processes
  • Work in a team matrix environment and independently interact with various levels of management
  • Excellent communication skills, both written and oral. Ability to effectively present information to all levels of the organization with appropriate messaging and effective focus on desired outcomes.
  • Ability to plan, monitor, and control a set of activities, ensuring efficient utilization of resources to achieve program objectives
  • A passion for compliance and documentation, follow up and critical analysis of compliance risks


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.

PI116956992

<b>Amgen</b><br/><br/><b>Job ID: </b>R-89288<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>The Senior Manager Quality Compliance will report directly to the Amgen Thousand Oaks (ATO) Quality Site Head and provide management and oversight for the following areas: ATO Internal Audit Program, QMS Compliance and Site Master File (SMF), Commitment Management, Regulatory certifications and declarations, Audit and Inspection Management, and GxP Intelligence coordination and management.<br><br><b>Job Responsibilities:</b><br><br><b> Internal Compliance: </b><br><br>ATO Internal Audit Program:<br><ul><li>Accountable for the establishment of a risk-based Master Audit Schedule (MAS)</li><li>Ensures internal audits are performed and completed per the approved MAS</li></ul><br><br>QMS Compliance Oversight:<br><ul><li>Responsible for the following reviews and evaluations: Biological Product Deviation Reports (BPDRs), Annual Product Reviews (APR), Complaint Reportability Evaluations, Recalls and Stock Recoveries, Procedure Reviews</li><li>Management Review: Compiles and reports Quality Compliance Metrics</li><li>Owns and manages the Site Master File per approved procedures to ensure accuracy and adherence to applicable regulations</li></ul><br><br>Commitment Management:<br><ul><li>Ensures integration of commitments into the appropriate QMS process and on-time commitment closure</li><li>Evaluates commitment applicability</li><li>Ensures life-cycle management of commitments</li><li>Collaborates with Regulatory Affairs to approve Quality & Regulatory Licenses and Certificates/Declarations</li></ul><br>QMS Continuous Improvements:<br><ul><li>Represents the ATO site on the Audits and Inspection Network (AIN) and Compliance Forum</li></ul><br><br><b> Inspection (including External Audit, Document Inspection and Experiential Visit) Management: </b><br><br>Responsible for implementing and sustaining the site Inspection Readiness Program plan with visible and measurable outputs. Performing tasks including but not limited to:<br><ul><li>Identification, tracking and reporting of top compliance concerns</li><li>Leading/participating in strategy and pressure test sessions</li><li>Verification of sustained commitment compliance</li><li>Maintaining a cross functional-trained resource pool for inspection management roles</li><li>Responsible for inspection planning, execution and post process management, including but not limited to:<ul><li>Coordination of inspection logistics</li><li>Oversight of inspection process execution</li><li>Serve as inspection lead and/or inspection escort</li><li>Own, lead and manage the post inspection process for response drafting, review, approval, submission and the global applicability process</li></ul></li></ul><br><br><b> GxP Intelligence & Regulatory Commenting </b><b>:</b><br><ul><li>Site representative for the triage, coordination, management and execution of reviews for global draft applicable regulations, in collaboration with other impacted organizations.</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>Associated degree and 10 years of Quality experience<br><br>OR<br><br>High school diploma / GED and 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<br><br><b> Preferred Qualifications: </b><br><ul><li>Broad knowledge of global regulatory compliance, global regulators and audits/inspections</li><li>Experience hosting or participating in regulatory inspections</li><li>Detail-oriented with experience in QA/QC functions across a broad range of manufacturing, QC and/or supply chain processes</li><li>Work in a team matrix environment and independently interact with various levels of management</li><li>Excellent communication skills, both written and oral. Ability to effectively present information to all levels of the organization with appropriate messaging and effective focus on desired outcomes.</li><li>Ability to plan, monitor, and control a set of activities, ensuring efficient utilization of resources to achieve program objectives</li><li>A passion for compliance and documentation, follow up and critical analysis of compliance risks</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/xWE4gLCmROwjfo6NuxWoB"> <p>PI116956992</p>

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Posted: 2020-01-09 Expires: 2020-02-09

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Senior Manager Quality Compliance

Amgen
Thousand Oaks, CA 91360

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