Senior Associate Quality Compliance

Amgen • Chicago, IL

8d • $89,168 - $120,640

About The Position

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-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.

Requirements

• Master’s degree OR Bachelor’s degree and 2 years of scientific or healthcare related experience OR Associate’s degree and 6 years of scientific or healthcare related experience OR High school diploma / GED and 8 years of scientific or healthcare related experience
• Knowledge and application of international requirements of Good Clinical Practice (GCP)(required) or Good Pharmacovigilance Practice (GPV) and/or Good Laboratory Practice (GLP)
• Knowledge of R&D processes and operations
• Knowledge of the Regulatory Submission and Inspection Management procedures
• Ability to work under pressure and maintain flexibility
• Attention to detail
• Knowledge of ICH E6R3 as well as 21 CFR 11, SO, 54, 56, 58, 312, and 812
• Proficiency in Microsoft Office
• Professional, proactive demeanor
• Strong interpersonal skills
• Excellent written and verbal communication skills

Nice To Haves

• Understanding of Clinical R&D activities and Global Regulations
• Experience working within GCP Quality Compliance preferred

Responsibilities

• Strengthen and advance Amgen’s R&D Quality Management System (QMS).
• Provide quality support for Amgen programs for all stages of products in clinical development.
• Input of audit responses into QMS.
• Input of site inspection data into the Inspection Management System.
• Working with deviation owners to ensure the timely development and closure of CAPAs. Ensuring deviation owners are submitting objective evidence within agreed timelines, where applicable.
• Ensuring the timely preparation and submission of documentation to the Potentially Reportable Serious Breach committee.
• Collaboration with the Clinical Study Team, as directed by the RDQ Compliance Manager, to facilitate communication.
• Prepare weekly metric reports for the General Medicine team, including, but not limited to, open deviations, CAPAs, serious breaches, audit and inspection findings. Highlighting overdue items and supporting the RDQ compliance managers to ensure timely closure.
• Working with the RDQ Compliance Manager and data quality analytics team to assess the effectiveness of metric reports and optimize as required.
• Facilitate Rare Disease team meetings, including agenda and presentation preparation. Maintain a Decision & Action log, follow up with action owners until resolution. Management of a Q&A log.
• Support inspection readiness activities under the supervision of the RDQ Compliance Manager.
• Quality oversight of small clinical programs under the guidance of the RDQ Compliance Manager.
• Demonstrated ability to leverage artificial intelligence (AI) tools and technologies to streamline workflows, drive process automation, and support data-driven decision-making. Must be adept at identifying opportunities to apply AI for operational efficiency and continuous improvement initiatives.
• Support the RDQ Compliance Manager to develop lessons learned and best practices documentation.
• Collaborate with other Amgen R&D Quality functions as required.
• Maintenance of Rare Disease SharePoint site and Teams channels.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior