Amgen
Senior Specialist Quality Compliance
Amgen, Holly Springs, North Carolina, United States, 27540
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
Senior Specialist Quality Compliance
Live!
What you will do
Let’s do this. Let’s change the world. In this vital role you will be part of the Regulatory Compliance function, the Senior Specialist of Inspection Lifecycle Management (ILM) will be involved in the preparation for, execution of and response to Regulatory Agency and Business Partner inspections at the Amgen North Carolina (ANC) site. Preparation includes cross-functional and cross-site collaboration along with a strong on site presence for assuring a perpetual state of inspection readiness for ANC. Execution of the inspections includes serving in roles with direct interaction with inspectors as well as serving in support rooms/functions as needed. The role also includes leading the generation of formal response commitments for the ANC site, cascading inspection outcome information across Amgen sites and functions, identifying improvement opportunities and tracking commitment and improvement actions to completion.
Being a part of the ILM team includes being responsible for establishing and maintaining best practice and effective inspection lifecycle processes from preparation/readiness through execution and inspection outcome processes, so they can be applied consistently across Amgen globally. The position will apply knowledge of current regulations, standards and guidelines, in addition to requirements of applicable Standard Operating Procedures (SOP’s), in the support of inspections.
In addition, the position may entail serving as a Subject Matter Expert (SME) for GMP compliance topics in support of various aspects of the Quality Management System (QMS), supporting Amgen's self-inspection program as well as being responsible for fulfilling various regulatory requests and documentation related to ANC site inspection/certification status.
Collaborate with functional areas and across Amgen in preparation for inspections
Perform site inspection readiness efforts including strategy sessions and pressure tests
Participate in inspections that may require direct/indirect interaction with regulators
Lead response and improvement actions resulting from Regulatory Agency and/or Business Partner inspections
Lead maintenance and continuous improvement for at least one (1) inspection lifecycle process stage and support all others
Represent site and Regulatory Compliance function on global networks
Provide clients with guidance on regulatory compliance expectations and trends
Provide leadership toward resolving site and multi-site compliance risks
Provide support to Regulatory submission teams
Support self inspection (internal audits) program
Perform tasks and participate on project teams as assigned to complete site, departmental, team and goals of the company.
Win!
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The quality compliance professional we seek is a leader with these qualifications.
Basic Qualifications:
High school diploma / GED and 12 years of Quality Compliance experience OR
Associate’s degree and 10 years of Quality Compliance experience OR
Bachelor’s degree and 6 years of Quality Compliance experience OR
Master’s degree and 4 years of Quality Compliance experience OR
Doctorate degree and 2 years of Quality Compliance experience
Preferred Qualifications:
Bachelor’s Degree in Life Sciences or Engineering
Experience with leading and/or participating in key roles to prepare for, execute and/or respond to outcomes from Health Authority inspections
Experience in auditing and defending processes, procedures and decisions during Health Authority inspections
7+ years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical industry with progressively increasing responsibility and proven experience in compliance, data analysis, project management, and quality systems
Experience managing staff and/or leading cross-functional teams, projects and/or programs
Thorough understanding of quality management systems and quality control processes related to bulk drug and drug product for clinical and commercial operations
Previous exposure to bulk drug and drug product manufacturing and quality assurance processes
Experience with facility start ups
Detailed solid understanding of EU and US Good Manufacturing Practices (cGMPs)
Proficiency in ability to work autonomously, present data in an organized and logical manner and an ability to communicate effectively.
Experience with process improvement projects
Proficiency in navigating through ambiguity and provide a structured problem-solving approach
Track record of building or participating as a member of impactful teams
Proficiency in coordinating and leading cross-functional project teams to deliver to expectations and on schedule
Ability to maintain remote working relationships with team mates at other Amgen sites in order to identify and align to standard methodologies
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
careers.amgen.com
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
Senior Specialist Quality Compliance
Live!
What you will do
Let’s do this. Let’s change the world. In this vital role you will be part of the Regulatory Compliance function, the Senior Specialist of Inspection Lifecycle Management (ILM) will be involved in the preparation for, execution of and response to Regulatory Agency and Business Partner inspections at the Amgen North Carolina (ANC) site. Preparation includes cross-functional and cross-site collaboration along with a strong on site presence for assuring a perpetual state of inspection readiness for ANC. Execution of the inspections includes serving in roles with direct interaction with inspectors as well as serving in support rooms/functions as needed. The role also includes leading the generation of formal response commitments for the ANC site, cascading inspection outcome information across Amgen sites and functions, identifying improvement opportunities and tracking commitment and improvement actions to completion.
Being a part of the ILM team includes being responsible for establishing and maintaining best practice and effective inspection lifecycle processes from preparation/readiness through execution and inspection outcome processes, so they can be applied consistently across Amgen globally. The position will apply knowledge of current regulations, standards and guidelines, in addition to requirements of applicable Standard Operating Procedures (SOP’s), in the support of inspections.
In addition, the position may entail serving as a Subject Matter Expert (SME) for GMP compliance topics in support of various aspects of the Quality Management System (QMS), supporting Amgen's self-inspection program as well as being responsible for fulfilling various regulatory requests and documentation related to ANC site inspection/certification status.
Collaborate with functional areas and across Amgen in preparation for inspections
Perform site inspection readiness efforts including strategy sessions and pressure tests
Participate in inspections that may require direct/indirect interaction with regulators
Lead response and improvement actions resulting from Regulatory Agency and/or Business Partner inspections
Lead maintenance and continuous improvement for at least one (1) inspection lifecycle process stage and support all others
Represent site and Regulatory Compliance function on global networks
Provide clients with guidance on regulatory compliance expectations and trends
Provide leadership toward resolving site and multi-site compliance risks
Provide support to Regulatory submission teams
Support self inspection (internal audits) program
Perform tasks and participate on project teams as assigned to complete site, departmental, team and goals of the company.
Win!
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The quality compliance professional we seek is a leader with these qualifications.
Basic Qualifications:
High school diploma / GED and 12 years of Quality Compliance experience OR
Associate’s degree and 10 years of Quality Compliance experience OR
Bachelor’s degree and 6 years of Quality Compliance experience OR
Master’s degree and 4 years of Quality Compliance experience OR
Doctorate degree and 2 years of Quality Compliance experience
Preferred Qualifications:
Bachelor’s Degree in Life Sciences or Engineering
Experience with leading and/or participating in key roles to prepare for, execute and/or respond to outcomes from Health Authority inspections
Experience in auditing and defending processes, procedures and decisions during Health Authority inspections
7+ years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical industry with progressively increasing responsibility and proven experience in compliance, data analysis, project management, and quality systems
Experience managing staff and/or leading cross-functional teams, projects and/or programs
Thorough understanding of quality management systems and quality control processes related to bulk drug and drug product for clinical and commercial operations
Previous exposure to bulk drug and drug product manufacturing and quality assurance processes
Experience with facility start ups
Detailed solid understanding of EU and US Good Manufacturing Practices (cGMPs)
Proficiency in ability to work autonomously, present data in an organized and logical manner and an ability to communicate effectively.
Experience with process improvement projects
Proficiency in navigating through ambiguity and provide a structured problem-solving approach
Track record of building or participating as a member of impactful teams
Proficiency in coordinating and leading cross-functional project teams to deliver to expectations and on schedule
Ability to maintain remote working relationships with team mates at other Amgen sites in order to identify and align to standard methodologies
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
careers.amgen.com