Commercial Programs Quality Oversight- Remote

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 change across functions.
• Demonstrated track record leading impactful teams within the biotechnology and/or pharmaceutical industry.
• Understanding of the legal and regulatory environment affecting PhRMA/Biotech
• Ability to create, grow, and develop high-performing teams that deliver outstanding business results.
• Experience fostering an environment that drives creativity and innovation.
• Ability to operate independently in a strategic and tactical manner and ability to work through ambiguity across GPvP in designing and implementing learning and training solutions.
• Ability to partner effectively with collaborators at senior and junior levels and develop broad-based solutions designed to meet a variety of organizational and business needs.
• Exceptional oral and written communication and writing skills.

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, 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, 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.

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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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