GCP Quality Compliance Manager

Join to apply for the GCP Quality Compliance Manager role at Bio Space

1 day ago Be among the first 25 applicants

Join to apply for the GCP Quality Compliance Manager role at Bio Space

Get AI-powered advice on this job and more exclusive features.

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnesses drives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll 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

Lets do this! Lets 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 Amgens 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

• 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.

• Doctorate degree OR
• Masters degree and 2 years of Quality/Compliance/Process Management experience OR
• Bachelors degree and 4 years of Quality/Compliance/Process Management experience OR
• Associates degree and 8 years of Quality/Compliance/Process Management experience Or
• High school diploma / GED and 10 years of Quality/Compliance/Process Management experience

• 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…