Represent Variation Management Organization (VMO) on Product Delivery Teams (PDTs), guide stakeholders through the process and assist with business case development
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)
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
Effective management of post-launch changes to products “variations” is critical.
This is especially true given the continued forecasted growth in 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 Variation Lead will be accountable for driving the cross-functional execution of a portfolio of variation projects for commercial products. 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 includes: business case approval for a change, variation portfolio prioritization, change control, supply and submission planning, and project execution through approval from global regulatory agencies and implementation into the supply chain.
Bachelor’s degree & 2 years of Operations or Regulatory experience
Associates degree & 4 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
Periodic travel to sites required up to 10%.
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
Some experience with a “variation management” process
"This posting is for Contingent Worker, not an FTE"