R&D Supplier Quality Sr Manager

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.

Key Areas of Responsibility

• 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 experts, and accountable functions.
• Partner with Quality and business stakeholders to establish fit-for-purpose supplier qualification and oversight strategies when activities cross traditional R&D and Operations boundaries.
• Support the development, negotiation, and maintenance of Quality Agreements and other supplier Quality requirements in collaboration with applicable subject matter experts.
• Collaborate with research and other functions to drive the implementation of continuous improvement initiatives.
• Function as the Quality lead for the execution of quality records related to R&D Supplier management activities.
• Define and maintain R&D Supplier Quality KPIs and metrics to identify trends, monitor key signals, and support timely and appropriate action.
• Drive timely escalation, documentation, and continuous improvement for supplier-quality risks, including issues that may affect patient safety, product quality, regulatory compliance, or clinical trial timelines.
• Operate effectively within a global, matrixed organization, coordinating across multiple functions and time zones.

Basic Qualifications

• Doctorate degree and 2 years of Quality Management or other relevant experience OR
• Master’s degree and 4 years of Quality Management or other relevant experience OR
• Bachelor’s degree and 6 years of Quality Management or other relevant experience OR
• Associate’s degree and 10 years of Quality Management or other relevant experience OR
• High school diploma / GED and 12 years of Quality Management or other relevant experience

Preferred Qualifications

• Experience in supplier quality management or oversight.
• Working knowledge of GCP, GLP, GPvP, GMP, and GDP regulations, practices, and trends.
• Experience in clinical supply chain Quality or oversight of other GMP/GDP-regulated services used in clinical development.
• Practical experience applying GMP and/or GDP requirements within a regulated life sciences environment.
• Ability to influence and drive progress across functions where direct reporting relationships or clear ownership may not exist.
• Effective and timely decision making and influencing skills executed in a timely manner
• Strong leadership, negotiation, critical thinking and analytical skills
• Skilled in both written and verbal communication for engaging with individuals at all levels within the organization.
• Ability to employ and implement various tools and systems supporting the supplier quality management processes.
• Excellent project management abilities, including coordination of complex cross-functional initiatives.
• Experience working in a global, matrix organization across multiple time zones.
• Experience supporting supplier quality oversight across a complex, cross-functional, or global operating environment.
• Experience in contract negotiations and relationship building with suppliers and service providers.
• Experience in transactional lean, value stream mapping, and identifying areas of process design and improvement.
• Ability to adapt to changing business needs and effectively navigate areas if ambiguity,
• Willingness and capability to travel up to 15%.