Sr Specialist Quality Compliance

Career Category

Operations

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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. J

Sr Specialist QA - Compliance

What you will do

Let’s do this. Let’s change the world. In this vital role, you will provide site-level leadership for inspection readiness across both manufacturing facilities, driving a sustained state of readiness for regulatory inspections, corporate and internal audits, and customer audits. You will lead the development and execution of readiness strategies, establish clear governance and accountability, and influence cross-functional partners to identify and address risks before they affect inspection outcomes. As a primary site coordinator, you will oversee inspection logistics including schedules, rooms, escorts, subject matter expert support, document retrieval, communications, and daily inspection management while adapting plans and resources as inspection priorities evolve. This role requires sound judgment, decisive action, and the ability to pivot quickly in a dynamic environment, align leaders and teams under time-sensitive conditions, and escalate emerging issues with clear recommendations.

Key Responsibilities:

• •Partner across functions to maintain a continuous inspection-ready state for a multi-product GMP manufacturing operation.
• •Develop, maintain, and continuously improve site inspection readiness programs, tools, trackers, playbooks, and governance processes.
• •Coordinate cross-functional readiness plans for upcoming Health Authority inspections and major audits, including mock inspections, war-room preparation, document review, and interview readiness.
• •Support inspection and audit strategy for new product introductions to ensure new processes, facilities, systems, documents, and personnel are inspection ready prior to implementation and filing-related activities.
• •Ensure inspection-related commitments, actions, and deliverables are clearly assigned, tracked to completion, and escalated as needed.
• •Facilitate cross-functional alignment on inspection narratives, site presentations, supporting data packages, and response coordination.
• •Support preparation and maintenance of core inspection readiness content, including site overviews, facility maps, product flow summaries, SME rosters, document inventories, and inspection support tools.
• •Coordinate document management and retrieval processes to support efficient and controlled responses during inspections and audits.
• •Monitor readiness of quality systems and operational processes that are commonly scrutinized during inspections, including deviations, CAPAs, change control, risk management, complaints, training, validations, document management, and data integrity controls.
• •Identify gaps, risks, or weak points that may affect inspection outcomes and work with functional owners to drive timely remediation.
• •Facilitate and manage monthly management review
• •Support site self-assessments and gap assessments against cGMP requirements, internal standards, and regulatory inspection trends.
• •Develop and sustain close working relationships with internal stakeholders and external business partners, to ensure aligned and effective audit and inspection support.
• •Ensure lessons learned from prior inspections, audits, commitments, and industry enforcement actions are incorporated into site readiness activities.
• •Track regulatory commitments and support timely follow-up to ensure inspection observations, actions, and commitments are completed and sustainable.
• •Provide compliance support during inspections, including schedule management, room coordination, request tracking, communication support, and facilitation of cross-functional issue resolution.
• •Support drafting, coordination, and review of inspection responses and related action plans, as applicable.
• •Escalate significant quality, compliance, supply, and inspection readiness risks to site quality and senior leadership.
• •Support continual improvement initiatives that strengthen site quality culture, inspection readiness capability, and execution discipline.

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 a collaborative leader with these qualifications.

Basic Qualifications

• •High school diploma / GED and 12 years of regulatory compliance experience OR
• •Associate’s degree and 10 years of regulatory compliance experience OR
• •Bachelor’s degree and 6 years of regulatory compliance experience OR
• •Master’s degree and 4 years of regulatory compliance experience OR
• •Doctorate degree and 2 years of regulatory compliance experience

Preferred Qualifications

• •Bachelor’s Degree in Life Sciences or Engineering
• •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 leading or coordinating inspection and audit activities, including managing information requests, preparing subject matter experts, supporting interviews, and coordinating inspection responses.
• •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/or defending processes, procedures and decisions during Health Authority inspections
• •Strong working knowledge of cGMP requirements and quality systems commonly assessed during inspections, including deviations, CAPAs, change control, training, validation, document management, and data integrity.
• •Demonstrated ability to work autonomously, present data in an organized and logical manner and an ability to communicate effectively
• •Demonstrated ability to identify compliance risks and readiness gaps, lead cross-functional remediation, and ensure actions are completed and sustained.
• •Experience managing staff and/or leading cross-functional teams, projects and/or programs
• •Thorough working knowledge of EU and US Good Manufacturing Practices (cGMPs)
• •Previous exposure to bulk drug substance manufacturing and quality assurance processes
• •Demonstrated ability to navigate through ambiguity and provide a structured problem-solving approach

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 reti