Associate Director Quality Compliance - Inspection Lifecycle Management
Amgen
Summary
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.
Job description
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.
- 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.
Requirements
- 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
- At least 3 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
- 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
Benefits
- Retirement and Savings Plan
- Medical, Dental & Vision
- Life & Disability Insurance
- Discretionary Annual Bonus
- Stock-based Long-term Incentives
- Paid Time Off
- Flexible Work Models
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.