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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.

Associate Director Quality Compliance, Inspection Lifecycle Management

What you will do

Let’s do this! Let’s change the world!

As part of the Regulatory Compliance function, the Associate Director 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 Thousand Oaks (ATO) 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 ATO. 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 ATO 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 standard methodology 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 regulatory regulations, standards and guidelines, in addition to requirements of applicable Standard Operating Procedures (SOP’s), in the support of inspections. 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 ATO site inspection/certification status.

In addition, this role will include managing ~2 direct reports from the ILM team to provide direct engagement for strategic direction and compliance guidance for those staffs.

Responsibilities Include:

• Collaborate with functional areas and across Amgen in preparation for inspections

• 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

• Leads maintenance and continuous improvement for at least one (1) inspection lifecycle process stage and supports all others

• Represent site and Regulatory Compliance function on global networks

• Provide clients with guidance on regulatory compliance expectations and trends

• Support self-inspection (internal audits) program

• Provide leadership toward resolving site and multi-site compliance risks

• Provide support to regulatory teams

• Perform tasks and participate on project teams as assigned to assist with the attainment of group, departmental, team and company goals

• Perform site inspection readiness efforts including strategy sessions and pressure tests

• Manage and provide strategic direction and compliance guidance to ~2 direct reports from the ILM team

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 individual with these qualifications.

Basic Qualifications:

• Doctorate degree and 3 years of regulatory compliance experience OR

• Master’s degree and 7 years of regulatory compliance experience OR

• Bachelor’s degree and 9 years of regulatory compliance experience OR

• Associate’s degree and 12 years of regulatory compliance experience OR

• High school diploma / GED and 14 years of regulatory compliance experience

In addition to meeting at least one of the above requirements, you must have a minimum of 3 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:

• 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 demonstrated experience in compliance, data analysis, project management, and quality systems

• Experience managing staff and/or leading cross-functional teams, projects and/or programs

• Thorough working knowledge of EU and US Good Manufacturing Practices (cGMPs)

• 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 (aka drug substance) and drug product manufacturing and quality assurance processes

• Demonstrated ability to work autonomously, present data in an organized and logical manner and an ability to communicate effectively

• Experience with process improvement projects

• Demonstrated ability to navigate through ambiguity and provide a structured problem-solving approach

• Track record of building or participating as a member of successful teams

• Demonstrated ability to coordinate and lead 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 processes

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 qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans

• Flexible work models, including remote and hybrid work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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