Associate Director Quality Compliance - Inspection Lifecycle Management

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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! In this vital role, you will be part of the Regulatory Compliance corporate function and serve as the Associate Director of Inspection Lifecycle Management (ILM) at the Amgen Manufacturing Limited LLC (AML) site. Your responsibilities will include, but are not limited to the following three key areas of accountability:

Serve as the AML Inspection Lifecycle Management (ILM) Drug Substance (DS) Representative

Partner directly with the AML ILM Drug Product and Finished Drug Product (DP/FDP) representative to support AML preparation for, execution of, and response to Health Authority and Business Partner inspections. Responsibilities include:

• Serve as a strong on-site Regulatory Compliance presence, collaborating across functions and sites to maintain a traceable, perpetual state of inspection readiness.
• Provide guidance on regulatory compliance expectations and trends; support Regulatory Affairs and self-inspection (internal audits) programs; and lead efforts to resolve site compliance risks.
• Perform and/or lead site inspection readiness activities, including strategy sessions and pressure testing for higher-risk topics.
• Support inspections through direct interaction with inspectors and participation in support rooms and other functions, providing guidance to address and anticipate inspector requests.
• Advise on the development of inspection responses, ensuring observations and findings are addressed thoroughly with consideration for global scope and best practices.
• Support the tracking of commitments and improvement actions through completion and cascade inspection outcomes across Amgen sites and functions to enable learning and improvement.

Lead the Centralization of DS Inspection Readiness Strategy Across Applicable ILM Sites

• Lead a network of ILM staff at DS processing sites, including at least three direct reports and at least two indirect reports at ILM sites with DS processing in addition to DP and/or FDP.
• Manage and develop direct reports by providing coaching, strategic direction, and compliance guidance.
• Establish and deploy DS inspection readiness maturity and performance standards across the ILM network.
• Own and synthesize DS-specific inspection intelligence from internal inspection outcomes, external Health Authority trends, and emerging regulatory focus areas to identify risks, communicate them to responsible areas, and advise on prioritized mitigation and readiness strategies.
• Partner with the centralized ILM DP/FDP network, the Global Process Owner for Inspections, and the Head of ILM to deliver an intelligence- and risk-based, end-to-end inspection readiness program.

Support Continuous Improvement of Global Inspection Lifecycle Tools, Systems, and Processes

• Identify, collect, and communicate best practices and improvement opportunities from inspection readiness, preparation, execution, and outcomes.
• Support the Global Process Owner for Inspections in continuously improving and deploying inspection lifecycle tools, systems, and processes across ILM sites.
• Serve as a Subject Matter Expert for applicable inspection lifecycle tools, systems, and processes.

What we expect of you
 

We are all different, yet we all use our unique contributions to serve patients! The Associate Director Quality Compliance we seek is a strategic and collaborative leader 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 at least 3 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above.
 

Beyond that, additional preferred qualifications are:

• Bachelor’s degree in Life Sciences or Engineering.
• 7+ years of related pharmaceutical industry experience in Manufacturing, Process Development, and/or Quality Assurance, with progressively increasing responsibility in compliance, data analysis, project management, and quality systems.
• Experience leading and/or participating in key roles to prepare, executing, responding to, auditing, and/or defending processes, procedures, and decisions during Health Authority inspections.
• Thorough knowledge of U.S. and EU current Good Manufacturing Practices (cGMPs), quality management systems, and quality control processes related to bulk drug substance commercial operations.
• Strong exposure to bulk drug substance manufacturing and quality assurance processes.
• Demonstrated people leadership experience, preferably across functions and/or sites, including the ability to develop and lead strategic roles, networks, and successful teams.
• Experience leading and influencing cross-functional, global, and/or enterprise-level Quality or Compliance programs, including executive leadership communications.
• Demonstrated ability to lead cross-functional project teams and process improvement initiatives, delivering results on schedule and to expectations.
• Ability to work autonomously, navigate ambiguity, apply a structured problem-solving approach, and present data clearly and logically.
• Ability to establish and maintain remote working relationships across Amgen sites to identify and align to standard processes.
• Fluent in English—both written and verbal with a strong communication skill.

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.

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 & vision coverage, and life & disability insurance
• 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

 

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

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Sponsorship

Sponsorship for this role is not guaranteed.

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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