GCP Quality Compliance Manager

Career Category

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. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. 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.

GCP Quality Compliance Manager

What you will do

Let’s do this! Let’s change the world! In this vital role you will provide critical support to the Process Quality function by assisting in the implementation, monitoring, and continuous improvement of Amgen’s R&D Quality Management System (QMS) and Regional Quality Oversight.

Accountabilities:

• Assist in maintaining and improving the QMS by helping to track, document, and implement quality initiatives, ensuring that procedures and processes meet regulatory requirements.

• Contribute to the collection, analysis, and reporting of quality metrics (KPIs, KQIs), helping to identify trends, risks, and areas for continuous improvement.

• Provide hands-on support to the Senior Manager/Associate Director in ensuring procedural compliance with GCP standards and other regulatory requirements across R&D.

• Act as a liaison between the Process Quality function and Global Networks supporting smooth collaboration and exchange of information.

• Provide quality oversight primarily for key target sites

• Perform focused readiness checks of clinical trials remote and onsite

• Perform risk assessment to support identification of sites for audits

• Identify data quality indicators/trends, identify areas of weakness/gaps, recommend and implement corrective actions

• Coordinate activities related to site/sponsor inspections and audits - preparation, conduct and close out and response generation

Key Capabilities:

• Understanding of SOP/Standards management and methods/technology used to drive knowledge management across a diverse R&D environment

• Communicate effectively

• Develops innovative and creative output based on interpretation and analysis

• In-depth disciplinary knowledge; uses business insight and subject matter expertise

• Employs project management techniques

• Thorough understanding of business priorities, strategy and direction

• Integrates trends, data and information into plans, deliverables and recommendations

• Manages root cause analysis and corrective/prevent action completion follow-up

• Acts as a technical expert in GCP

• Employs critical thinking skills

• Able to separate critical from non-critical issues

• Strong attention to detail and proficiency in managing data and reports.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The individual we seek has technological literacy and leadership skills and has these qualifications.

Basic Qualifications:

• Doctorate degree OR

• Master’s degree and 2 years of Quality/Compliance/Process Management experience OR

• Bachelor’s degree and 4 years of Quality/Compliance/Process Management experience OR

• Associate’s degree and 8 years of Quality/Compliance/Process Management experience Or

• High school diploma / GED and 10 years of Quality/Compliance/Process Management experience

Preferred Qualifications:

• 2 years or more experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality management and quality by design are a core responsibility.

• Solid understanding of SOP/Standards management and methods/ technology used to drive knowledge management across a diverse R&D environment.

• Thorough understanding of Clinical R&D activities and Global Regula