Commercial Programs Quality Oversight and Monitoring lead

Career Category

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.

Commercial Programs Quality Oversight and Monitoring lead

What you will do

Let’s do this. Let’s change the world. In this vital role you will provide quality oversight for Patient Support Programs, Market Research, Digital Health, Websites and Social Media working closely with Commercial and Medical. The lead of Commercial Programs and Monitoring Quality will provide guidance to Amgen senior stakeholders including Commercial, Global Patient Safety, Regulatory Affairs and Operations to identify and resolve Quality issues and mitigate compliance risk. They will provide expert advice on Pharmacovigilance programs, initiatives, and activities to help manage and mitigate risk and to build in quality at the rime of process creation. Report and increase significant compliance issues to R&D Quality management and senior collaborators. Ensure proactive identification, customer concern, management, and remediation of compliance issues relating to Amgen processes, programs, and external relationships.

Responsibilities:

• Line Manager of professional staff in the range of 2 to 4 individuals.
• Development and conduct of the annual audit program for Patient Support Programs, Market Research, Digital Health, Websites and Social Media.
• Lead Audits and Monitoring Visits (External Engagement) and staff across Quality teams for all Amgen Products.
• Facilitate and review responses to inspections, audits and monitoring visits, with timely and appropriate remediation of audit and inspection findings.
• Advance Risk Based thinking, Proactive Quality Management and Quality by Design, including the following core activities: Audit Management​ Contract Review and Negotiation, Vendor Oversight, Inspection Preparation, Management, & Execution, eviation/ CAPA Management, and Privacy Issues.
• Serve as the PV representative on senior compliance/ quality oversight bodies. E.g., Safety Reporting for Commercial Programs (SRCP).
• Understands impact of emerging regulatory trends and their implications for Amgen
• Analyzes and forecasts regulatory trends.
• Develops complex solutions to problems through in-depth analysis, coordination, and negotiation with key decision makers.
• Adapts and integrates own experience with Amgen-wide strategy.
• Participates in Industry forums designed to benchmark and continuously improve in the areas of GPvP Quality Management.
• Lead the Deviations process in the Safety & Medical Quality team as part of the implementation of Amgen's new Quality management system.

What we expect of you

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

Basic Qualifications:

Doctorate degree and 3 years of R&D, Operations and/or Quality experience in the PhRMA/Biotech sector

Or

Master’s degree and 7 years of R&D, Operations and/or Quality experience in the PhRMA/Biotech sector

Or

Bachelor’s degree and 9 years of R&D, Operations and/or Quality experience in the PhRMA/Biotech sector

Or

Associate’s degree and 12 years of R&D, Operations and/or Quality experience in the PhRMA/Biotech sector

Or

High school diploma / GED and 14 years of R&D, Operations and/or Quality experience in the PhRMA/Biotech sector

In addition to meeting at least one of the above requirements, you must have a minimum of 3 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• Experience managing GPvP Quality Management including motivating chang