R&D Supplier Quality Sr Manager

Career Category Quality 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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer.

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! R&D Quality has developed a Supplier Quality Oversight capability with the primary objective of delivering a robust, risk-based supplier quality program capable of identifying key leading indicators that predict and prevent critical quality issues. This role as R&D Supplier Quality Senior Manager will report to R&D Supplier Quality leadership within Precision Medicine, Diagnostics and Supplier Quality (PMDSQ) and will be responsible for the Quality oversight of GxP regulated suppliers and service providers used in the R&D organization, with particular focus on those supporting clinical development activities involving GMP and GDP regulated services This role requires a dedicated professional with a passion for quality management and the ability to identify and execute process improvements, ensuring the highest operational standards.

This role involves establishing and cultivating robust, quality-focused relationships with Amgen suppliers and service providers, contributing risk-based assessments, during supplier evaluation and selection based on applicable regulatory requirements and supplier policies, procedures, and practices, managing related records efficiently and compliantly, and ensuring prompt escalation of high‑risk issues to leadership. A key component of this role will be supporting a cross‑functional forum that bridges R&D and Operations to address clinical activities involving GMP/GDP requirements or other situations where responsibilities span GxP or functional boundaries.

The Senior Manager will help support risk‑based triage, stakeholder engagement, decision‑making, escalation, and follow‑through when regulatory applicability, supplier qualification requirements, Quality responsibilities, or functional ownership are unclear. The successful candidate will bring strong practical knowledge and experience in GMP and GDP, complemented by experience within GCP and clinical development, along with strong project management, Quality Risk Management, facilitation, and cross‑functional leadership skills.

• Provide risk‑based Quality governance and oversight for R&D suppliers, with a focus on hybrid clinical suppliers whose services span GCP, GLP, GPvP, GMP, and GDP‑requirements.
• Support and facilitate a cross‑functional R&D and Operations forum for clinical quality issues involving GMP/GDP requirements, unclear ownership, or multiple functional stakeholders.
• Coordinate intake and risk‑based triage of complex clinical supplier and Quality issues, including identification of applicable requirements, potential Quality and business risks, required subject matter…