Sr Specialist QA - Compliance

About the role

Join Amgens 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 lie 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 continual improvement initiatives that strengthen site quality culture, inspection readiness capability, and execution discipline.

Qualifications

• Basic Qualifications
• Bachelors Degree in Life Sciences or Engineering
• High school diploma/GED and 12 years of regulatory compliance experience
• Associates degree and 10 years of regulatory compliance experience
• Bachelors degree and 6 years of regulatory compliance experience
• Masters degree and 4 years of regulatory compliance experience
• Doctorate degree and 2 years of regulatory compliance experience

Preferred Qualifications

• 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
• 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 substance for commercial operations
• Previous exposure to bulk drug substance manufacturing and quality assurance processes
• Demonstrated ability to work autonomously, present data in an organized and logical manner and an ability to communicate effectively
• Demonstrated ability to navigate through ambiguity and provide a structured problem-solving approach
• Demonstrated ability to coordinate and lead cross-functional project teams to deliver to expectations and on schedule

Pay

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.

Schedule

Actual schedule will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.