Specialist Supply Chain Compliance

Specialist Supply Chain Compliance – Louisville, KY
Salary range: $–$
Posted 1 day ago

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 a focus on 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 while growing yourself.

In this vital role you will collaborate cross‑functionally with other Amgen business units to ensure supply‑chain compliance and continuous improvement.

• Own and manage deviations, trend investigations records, CAPA and CAPA EV records. Lead root cause analysis sessions.
• Own and manage the trend trigger and periodic evaluation report for temperature excursions and distribution complaints.
• Provide training sessions related to SC Compliance.
• Act as Subject Matter Expert (SME) for the Quality Systems Deviation, CAPA, CAPA EV, Temperature excursion, Distribution Complaint and Periodic monitoring.
• Participate in and support inspection readiness activities, audits and inspections.
• Deploy new (global) capabilities and projects as appropriate.
• Support change management and operational excellence initiatives to improve process compliance performance.
• Author and own documents (procedures, forms, manuals, training materials, etc.) for the SC Compliance team.
• Lead event review meetings for missing product events.
• Perform data analysis for management reviews of the quality system on a periodic basis.
• Incidentally own and manage temperature excursion records of products.
• Provide guidance in all areas of GDP and FMD.

• Responsible for hiring, training, supervising, coaching, and performance management of SC Compliance staff.

The dynamic professional we seek is a self‑starter with these qualifications.

• Doctorate degree
• Or Master’s degree and 2 years of Supply Chain experience
• Or Bachelor’s degree and 4 years of Supply Chain experience
• Or Associate’s degree and 8 years of Supply Chain experience
• Or high school diploma/GED and 10 years of Supply Chain experience

• Experience in audit / inspection support
• Technical writing skills

We support your professional and personal growth through a competitive benefits package and a collaborative culture. Your salary is based on experience and qualifications, and we offer a total rewards plan, health and welfare plans, financial plans, work/life balance, and career development opportunities.

• 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 for details)

Final date to receive applications:
Amgen does not have an Final date to receive applications for this position; we will continue accepting applications until we receive a sufficient number or select a candidate.

Sponsorship for this role is not guaranteed.

Amgen welcomes applicants with inclusive, diverse, and highly competent teams. We are 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 provide reasonable accommodation for individuals with disabilities.