Senior Variation Lead

Job Summary

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.

Role Overview:

Effective management of post-launch changes to Amgen's products "variations" is critical. This is especially true given the continued forecasted growth in Amgen's product portfolio and international expansion. Drivers of product change are quite varied and include but are not limited to: response to patient safety issues, regulatory commitments, addressing supply requirements, manufacturing network strategy, commercial or regional strategy, labeling changes, and operational excellence projects.

The Senior Variation Lead will be accountable for driving the cross-functional execution of a portfolio of variation projects for Amgen's commercial products. The position will be a great opportunity to help design, establish and build a high-performing team and capability that will support the end-to-end variation management process. Holistically, this group will be focused on robust project, portfolio, and process management for variations to capture and accelerate the value of change to our commercial products.

The scope of the variation management process directionally includes: business case approval for a change, variation portfolio prioritization, change control, supply and submission planning, content authoring, publishing, submission, and approval from global regulatory agencies.

Key Responsibilities:

• Directly manage 2+ junior variation leads
• Maintain training materials, train staff on process, ensure reports are performing at high level
• Represent Variation Management Organization (VMO) on PDT(s), guide stakeholders through process and assist with business case development
• Lead cross-functional stakeholders in development of a variation business case for single-product and cross-product variations
• Lead cross-functional stakeholders in development of global variation project plans
• Drive end-to-end execution of a PDT's portfolio of variation projects (from business case through global regulatory approvals)
• Project Manage more complicated cross-product variations which require coordination across PDTs and with multiple variation leads
• Communicate priorities to product, functional, and regional stakeholders, identify and resolve issues, escalate to appropriate governance as needed
• Adhere to processes and best practices set by Business Process Owner, drive continuous improvement of processes
• Shepard variations through governance process
• Standardize and integrate project management tools; establish single source of truth for variation status
• Periodic travel to sites required up to 10%.

Basic Qualifications:

Doctorate degree

OR

Master's degree & 2 years of Operations or Regulatory experience

OR

Bachelor's degree & 4 years of Operations or Regulatory experience

OR

Associates degree & 6 years of Operations or Regulatory experience

• 6 + years biotech or pharmaceutical industry experience
• Able to facilitate and influence senior clients and partners
• Able to successfully manage workload to timelines
• Familiarity with basic project management tools
• Ability to negotiate a strategic position after taking feedback from multiple sources

Preferred Qualifications:

• Aptitude for managing direct reports
• Strong project management, problem-solving, and analytical skills; experience with project management tools
• Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality results
• Collaborates and communicates well with others, able to balance divergent inputs from various stakeholders and drive issue resolution
• Ability to operate in a matrixed or team environment with site, functional, and executive leadership
• Comfortable in "start-up" environment of a new Amgen group
• Experience driving decision making using DAI principles
• Some experience with the "variation management" processes

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, or disability status.