Senior Manager Corporate Quality Compliance
Career Category
Quality
Job Description
Join Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Global Quality Compliance, Senior Manager
What you will do
Let’s do this. Let’s change the world.
Responsible for executing Global Quality Compliance assigned tasks and/or projects necessary to achieve corporate and departmental goals including the following activities:
Coordinates and leads or participates in Global Quality Compliance Audits of Corporate Quality Management System, Amgen sites, Contract facilities, Affiliates, Critical Service Providers, Suppliers, Partners, and Wholesalers to assess compliance with all applicable regulations and to identify top compliance risks.
Ensure completion, maintenance, and sustainability of the assigned training per specific roles to support the audit process (e.g., read and understand how to apply regulatory requirements including changes to regulations, guidelines and standards, trends and expectations, as applicable).
Supports preparation of the annual audit plans, as assigned
Assesses state of compliance with appropriate regulations and participation in the assessment of action plans to correct deficiencies.
Provides technical and organizational leadership toward resolving site and multi-site compliance issues.
Alerts executive management of significant quality, and compliance risks.
Serves as subject matter expert on global regulated requirements and inspectional commitments, as applicable
Provides support for domestic and international Regulatory Authority Inspections when necessary.
Serves as senior Global Quality Compliance representative on cross-functional teams (e.g., QMS, GPO, ALF, and special task forces) and interacts with other departments in order to achieve goals.
Interacts with other functional area leads to ensure that Amgen Standards, strategies, and direction are aligned with existing regulations and regulatory expectations.
Provides support for audit and inspection metrics, as necessary.
Supports Continual Improvement initiatives, programs, and projects.
Owns or performs QA approval for DQMS Quality Event records (Quality Incident, Deviation, CAPA, Change Control, EV for GQC and Audits & Inspections network as required).
Additional Requirements:
Experience with Aseptic Processing, Drug Product, Drug Substance, Combination Products, Data Integrity
Certified Quality Auditor (CQA) or equivalent
Travel: Domestic and International Approximately 50%
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of auditor experience OR
Master’s degree and 6 years of auditor experience OR
Bachelor’s degree and 8 years of auditor experience OR
Associate’s degree and 10 years of auditor experience OR
High school diploma / GED and 12 years of auditor experience
In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
Preferred Qualifications:
Auditing experience in internal audit, affiliate, CMO, Contract laboratory, Transportation/Logistic/Distribution/ warehouse services,
50 % international travel requirement
Knowledge of international regulations and standards
Auditing certification preferred
Detail oriented
Organizational and multi task skills
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and
Quality
Job Description
Join Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Global Quality Compliance, Senior Manager
What you will do
Let’s do this. Let’s change the world.
Responsible for executing Global Quality Compliance assigned tasks and/or projects necessary to achieve corporate and departmental goals including the following activities:
Coordinates and leads or participates in Global Quality Compliance Audits of Corporate Quality Management System, Amgen sites, Contract facilities, Affiliates, Critical Service Providers, Suppliers, Partners, and Wholesalers to assess compliance with all applicable regulations and to identify top compliance risks.
Ensure completion, maintenance, and sustainability of the assigned training per specific roles to support the audit process (e.g., read and understand how to apply regulatory requirements including changes to regulations, guidelines and standards, trends and expectations, as applicable).
Supports preparation of the annual audit plans, as assigned
Assesses state of compliance with appropriate regulations and participation in the assessment of action plans to correct deficiencies.
Provides technical and organizational leadership toward resolving site and multi-site compliance issues.
Alerts executive management of significant quality, and compliance risks.
Serves as subject matter expert on global regulated requirements and inspectional commitments, as applicable
Provides support for domestic and international Regulatory Authority Inspections when necessary.
Serves as senior Global Quality Compliance representative on cross-functional teams (e.g., QMS, GPO, ALF, and special task forces) and interacts with other departments in order to achieve goals.
Interacts with other functional area leads to ensure that Amgen Standards, strategies, and direction are aligned with existing regulations and regulatory expectations.
Provides support for audit and inspection metrics, as necessary.
Supports Continual Improvement initiatives, programs, and projects.
Owns or performs QA approval for DQMS Quality Event records (Quality Incident, Deviation, CAPA, Change Control, EV for GQC and Audits & Inspections network as required).
Additional Requirements:
Experience with Aseptic Processing, Drug Product, Drug Substance, Combination Products, Data Integrity
Certified Quality Auditor (CQA) or equivalent
Travel: Domestic and International Approximately 50%
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of auditor experience OR
Master’s degree and 6 years of auditor experience OR
Bachelor’s degree and 8 years of auditor experience OR
Associate’s degree and 10 years of auditor experience OR
High school diploma / GED and 12 years of auditor experience
In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
Preferred Qualifications:
Auditing experience in internal audit, affiliate, CMO, Contract laboratory, Transportation/Logistic/Distribution/ warehouse services,
50 % international travel requirement
Knowledge of international regulations and standards
Auditing certification preferred
Detail oriented
Organizational and multi task skills
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and