GCP Quality Compliance Manager

GCP Quality Compliance Manager

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 missionto serve patients living with serious illnessesdrives 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.

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 :

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 :

Preferred Qualifications :

What You Can Expect From Us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.

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.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work / life balance, and career development opportunities that may include :

Apply now and make a lasting impact with the Amgen team.