Sr Specialist QA - Compliance

About the role

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.

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.
• Career Development Opportunities
• 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.

Requirements

• 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