R&D Supplier Quality Sr Manager

Amgen; United States; À distance; USD 132 000 - 179 000; Plein temps

Résumé du poste

Amgen is seeking an R&D Supplier Quality Senior Manager to lead quality oversight of GxP suppliers supporting clinical development. You will drive risk-based decisions, govern supplier quality programs, and partner across R&D and Operations to ensure patient safety and regulatory compliance.

The role requires strong leadership, project management, and knowledge of GMP, GDP, and GCP within a global matrix environment. Travel up to 15% may be required.

Qualifications

• Doctorate with 2+ years of Quality Management or related experience
• Master’s with 4+ years of Quality Management or related experience
• Bachelor’s with 6+ years of Quality Management or related experience

Responsabilités

• Provide risk-based Quality governance and oversight for R&D suppliers, spanning GMP and GDP requirements.
• Facilitate cross-functional R&D and Operations forums for clinical quality issues involving GMP/GDP.
• Coordinate intake and triage of complex supplier and Quality issues with SME involvement.
• Establish fit-for-purpose supplier qualification and oversight strategies across R&D and Operations.
• Develop, negotiate and maintain Quality Agreements with applicable subject matter experts.
• Drive continuous improvement initiatives in collaboration with research and other functions.
• Lead Quality activities for execution of Quality records related to R&D supplier management.
• Define KPIs and monitor trends to drive timely action on supplier quality risks.
• Escalate issues implementing risk-based decisions across a global matrix organization.

Connaissances

Quality governance

Cross-functional leadership

Regulatory knowledge

GxP awareness

Formation

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Description du poste

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.

R&D Supplier Quality Senior Manager

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.

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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

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%.

What you can expect of 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:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

Salary Range

132,037.30USD -178,638.70USD