R&D Supplier Quality Manager

Amgen Inc. (IR); Thousand Oaks (CA); Hybrid; USD 104.000 - 141.000; Vollzeit

Benefits dieser Stelle

Retirement plan

Stock-based incentives

Flexible work arrangements

Zusammenfassung

Amgen Inc. is seeking an R&D Supplier Quality Manager to ensure supplier quality across the R&D pipeline, including GxP computerised systems, data integrity, and regulatory compliance.

The role collaborates with Quality, Procurement, R&D, IS, and Cybersecurity to drive risk-based oversight and continuous improvement. Responsibilities include risk-based supplier assessments, audits, CAPA management, and support for regulatory responses.

Qualifikationen

• Doctorate degree or Master’s degree with 2+ years in science/engineering or related field; or Bachelor’s with 4+ years; or Associate’s with 8+ years; or HS diploma with 10+ years in related science/engineering field.

Aufgaben

• Conduct risk-based supplier assessments and lifecycle management.
• Lead qualification and oversight of suppliers using GxP computerized systems.
• Audit supplier GxP computerized systems and related quality processes.
• Plan and document supplier quality audits and CAPA effectiveness.
• Coordinate supplier governance reviews and regulatory readiness.

Kenntnisse

Quality management

Supplier quality

GxP compliance

Audits

Risk assessment

Data integrity

Cross-functional collaboration

Ausbildung

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Tools

Veeva

TrackWise

Jobbeschreibung

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 Manager

What you will do Let’s do this. Let’s change the world. Amgen is seeking a highly motivated R&D Supplier Quality Manager to support the qualifications, oversight, and continuous improvement of suppliers that contribute to Amgen’s R&D pipeline and our mission to serve patients. In this role you will support the operational execution of supplier quality management processes for R&D suppliers under GCP, GLP, and GPvP regulations, including suppliers that provide, host, develop, validate, maintain, or support GxP computerized systems used to support regulated preclinical and clinical activities. Working cross-functionally with stakeholders across Quality, Procurement, R&D, Information Systems, Cybersecurity, Privacy, and business process owners, you will provide hands‑on oversight of third‑party suppliers to ensure compliance, data integrity, patient safety, risk mitigation, and continuous improvement across the supplier lifecycle.

Key Responsibilities

• Conduct risk-based supplier assessments, qualification, audit and lifecycle management, including quality agreements across various R&D service categories.
• Lead or support risk-based qualification and ongoing oversight of suppliers that utilize and/or provide GxP computerized systems, interfaces and devices to support clinical and preclinical activities.
• Assessment and oversight of supplier AI-Enabled GXP computerized systems used to support clinical and preclinical activities ensuring compliance to defined procedural controls, policies and standards.
• Plan, lead, and document risk-based audits of supplier GxP computerized systems and associated quality processes to assess regulatory compliance, validation and lifecycle controls, data integrity, security, and the effectiveness of corrective and preventive actions.
• Assess supplier quality systems and controls for computerized system lifecycle management, including validation, data integrity, security, access management, change and configuration management, incident and problem management, backup, recovery, business continuity, and decommissioning.
• Review risk-appropriate quality and technical requirements in supplier contracts and quality agreements, including validation documentation, audit trails, electronic records and signatures, subcontractor controls, regulatory inspection support, data ownership, data retention, and notification of significant changes or incidents.
• Participate in supplier governance and periodic reviews; evaluate service performance, validation status, changes, deviations, incidents, audit outcomes, emerging risks, and CAPA effectiveness, and elevate material GxP or data integrity concerns.
• Support inspection readiness and regulatory responses related to supplier’s computerized systems; partner with system owners and subject‑matter experts on supplier risk acceptance, remediation, continuity, transition, and exit decisions.
• Monitor supplier performance, track KPIs, and elevate quality issues when appropriate.
• Coordinate and/or execute supplier audits, manage findings, initiate quality records, and ensure timely CAPA closure.
• Maintain supplier data in quality systems (e.g., Veeva, TrackWise) to ensure accuracy and inspection readiness.
• Engage with suppliers to align requirements, governance and process improvement initiatives.
• Ensure compliance with procedures, perform quality checks, and contribute to continuous improvement.
• Collaborate with internal teams (R&D, Supply Chain, Sourcing, QA) to assist in the development and execution of supplier quality strategies.
• Travel Up to 10% domestic and international travel may be required for supplier engagements and audits.

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 a collaborative partner with these qualifications

Basic Qualifications

Doctorate degree OR Master’s degree and 2 years of Science, Engineering, or experience in a related field OR Bachelor’s degree and 4 years of Science, Engineering, or experience in a related field OR Associate’s degree and 8 years of Science, Engineering, or experience in a related field OR High school diploma / GED and 10 years of Science, Engineering, or experience in a related field

Preferred Qualifications

• Master’s degree or equivalent in Life Sciences or Engineering.
• Knowledge of GxP, ISO standards, and regulatory expectations for R&D suppliers.
• Experience with supplier quality risk assessment tools and audit practices.
• Working knowledge of computerized system validation and assurance principles, risk-based system lifecycle practices, and applicable expectations for electronic records, electronic signatures, audit trails, and data integrity.
• Experience assessing or overseeing GxP technology suppliers, including software, software‑as‑a‑service, cloud, hosting, infrastructure, implementation, validation, and managed service providers.
• Ability to evaluate supplier audit reports, validation plans and reports, requirements and traceability, testing evidence, security and continuity controls, change records, deviations, CAPAs, and service performance data.
• Experience and proficiency in overseeing AI-enabled GxP systems, including risk assessment, governance, validation, data integrity, and ongoing supplier monitoring.
• Excellent written and verbal communication skills.
• Ability to work effectively in cross‑functional teams and in a matrixed environment.
• Strong problem‑solving and critical thinking abilities.
• Detail‑oriented with a continuous improvement mindset.
• Proactive collaboration and relationship‑building skills.
• Ability to manage multiple priorities and deliver results under timelines.

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:

• 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.

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

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 104,287.35USD -141,094.65 USD

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen