Supply Chain Mgr (Deviation Lead)
Top focus
Career Category Supply Chain 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. 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, 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. SUPPLY CHAIN MANAGER (DEVIATION LEAD) What you will do Let’s do this.
Let’s change the world. In this vital role, you will support Supply Chain Quality Systems and Compliance Operations by ensuring the effective management, execution, and continuous improvement of quality systems within a GMP/GDP-regulated environment.
You will apply quality, compliance, operational, and technical expertise to maintain inspection readiness, support product supply, and drive a culture of continuous improvement. Specific responsibilities include but are not limited to: Quality Systems Management Manage and continuously improve Supply Chain Quality Systems, including deviations, temperature excursion quality events, CAPAs, effectiveness verifications, change controls, risk assessments, and associated quality records.
Lead quality event investigations by conducting root cause analyses, assessing quality, compliance, and business impacts, implementing risk-based corrective and preventive actions, and verifying their effectiveness. Evaluate and approve risk assessments, change controls, product impact assessments, and disposition decisions to ensure compliance with regulatory requirements, product quality standards, and business continuity.
Compliance and Investigation Support Apply technical and operational expertise to assess supply chain processes, equipment, systems, environmental conditions, and data integrity risks; perform data analysis and trend monitoring; and author compliant quality records, investigations, and risk assessments.
Serve as a Subject Matter Expert (SME) for quality systems, investigations, quality event classification, risk management, and compliance practices. Continuous Improvement and Operational Excellence Analyze quality metrics and performance trends to identify systemic issues, emerging risks, and opportunities to improve quality system effectiveness, compliance, operational efficiency, and supply chain performance.
Lead and support continuous improvement and strategic initiatives that strengthen quality culture, inspection readiness, operational excellence, and product supply reliability. Inspection Readiness and Regulatory Compliance Maintain inspection readiness and support internal audits, supplier audits, self-inspections, and regulatory inspections, including preparation, response coordination, remediation planning, and implementation of compliance improvement actions.
Cross-Functional Collaboration Partner with cross-functional stakeholders to assess quality and business impacts, resolve compliance issues, provide guidance on quality systems and risk management practices, and support strategic business objectives.
What we expect of you We are all different! Yet, we all use our unique contributions to serve patients. The Supply Chain Manager professional we seek is an individual contributor leader with these qualifications
Basic Qualifications
- Doctorate degree Or Master’s degree and 2 years of Operations Support experience in GMP regulated environment Or Bachelor’s degree and 4 years of Operations Support experience in GMP regulated environment Or Associate’s degree and 8 years of Operations Support experience in GMP regulated environment Or High school diploma / GED and 10 years of Operations Support experience in GMP regulated environment Preferred Qualifications: Experience in GMP-regulated operations and Quality Systems, including deviation management, risk assessments, CAPAs
- change control processes.
- Knowledge of regulatory requirements and compliance practices.
- Expertise in Root Cause Analysis and structured problem-solving methodologies (e.g., Fishbone, Six Boxes, 5 Whys).
- Experience in supply chain operations, including receiving, warehousing, dispensing, and shipping.
- Strong technical writing, presentation, and facilitation skills.
- Proven ability to lead cross-functional investigations and problem-solving activities.
- Strong collaboration skills with Manufacturing, Process Development, Supply Chain, Engineering, and Quality organizations.
- Strong written and verbal communication skills in English and Spanish.
- Effective project management and organizational skills.
- What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
- In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance
- career development opportunities including: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage
- life & disability insurance A discretionary annual bonus program
- for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans and an annual site shutdown Flexible work models, including remote work arrangements
- possible Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth
- dates of school attendance or graduation.
- You will not be penalized for redacting or removing this information.
- 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 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 you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
- 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
- to receive other benefits and privileges of employment.
- Please contact us to request accommodation. .