Demo

R&D Supplier Quality Senior Manager

BioSpace
Washington, DC Full Time
POSTED ON 1/13/2025
AVAILABLE BEFORE 2/7/2025
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 illnessesdrives 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.

R&D Supplier Quality Senior Manager

What You Will Do

Lets do this. Lets change the world. R&D Quality is developing a Supplier Quality Oversight capability with the primary objective of delivering a robust, risk-based supplier quality program capable of identifying key leading indicators which will predict and prevent critical quality issues.

This role as R&D Supplier Quality Senior Manager will report to the Director, R&D Supplier Quality Management in Precision Medicine, Diagnostics and Supplier Quality (PMDSQ) and will be responsible for the Quality oversight of GCP, GLP and GPvP regulated suppliers and service providers used in the R&D organization. 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.

The role involves establishing and cultivating robust, quality-focused relationships with Amgen suppliers, providing risk-based quality supervision during supplier evaluation and selection, managing supplier-related quality records efficiently and compliantly, and ensuring prompt escalation of high-risk issues to leadership.

Furthermore, candidates should be, along with the ability to employ or implement various tools to support supplier quality processes.

Key Areas Of Responsibility

  • Quality-oversee supplier management, ensuring compliance with industry standards and best practices
  • Participate in negotiations of contractual agreements with suppliers and build strong long-term relationship with their quality organizations
  • Operate efficiently within a global, matrixed organization, coordinating effectively across multiple time zones
  • 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 KPI/Metrics to ensure timely and appropriate response to key quality signals


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
  • Masters degree and 4 years of Quality Management or other relevant experience OR
  • Bachelors degree and 6 years of Quality Management or other relevant experience OR
  • Associates 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 and GPvP regulations, practices, and trends
  • Excellent project management abilities
  • Experience working in a global, matrix organization across multiple time zones
  • Experience in contract negotiations and relationship building with suppliers
  • Experience in transactional lean, value stream mapping, and identifying areas of process design and improvement
  • Ability to adapt to changing business needs
  • 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.
  • Capability to employ or implement various tools in support of the supplier quality processes.
  • 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, well 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, including remote and hybrid work arrangements, where possible


Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, 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 and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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