Location
Newbury Park, CA, United States
Posted on
Feb 26, 2022
Profile
HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Regional Operations Manager
Live
What you will do
Lets do this. Lets change the world. In this dynamic role you will in implement the Latin-America (LATAM) Regions commercial strategy, product launch and lifecycle plans. The Regional Operations Manager role will include cross functional collaboration to establish new supply routes, supply sites, distribution models, setting up systems, managing variations, and overall launch coordination. Responsibilities include:
Serve as Operations champion for Latin America commercialization plan of action for assigned product(s)
Lead Regional Operations Team Meetings to manage launch and product life-cycle deliverables
Lead cross functional meetings and ensure plans are in place, valid and clearly communicated
Represent the region and country at the Product Delivery Team (PDT); attend PST meetings as needed
Participate in Joint ventures and partnership management activities for assigned products and represent Operations and Supply chain for the region and countries at the Global, Regional, site and/or country meetings as needed
Regularly and clearly communicate regions decision, risks, and project timeline to the PDT and appropriate Operations management/governance
Generate project charters and ensure project gate reviews are in alignment with international commercialization process; manage within regional budget requirements
Participate in Operational Excellence opportunities and drive regional improvements and cost savings by using Network Knowledge sharing forums
Coordination with Regions, Affiliates, Corporate Supply Chain, Contract Sites and Amgen sites to ensure supply with operations strategy and inventory management agreements.
Own uninterrupted patient supply, supply risk assessment and mitigation plans for assigned products
Support Demand and Supply Alignment activities for assigned product/market
Represent the supply network and collaborate with regions cross functional team (Commercial, Finance, Regulatory Affairs, Quality) to develop compliant product supply strategy for the planning horizon
Represent the region commercial needs and work with supply network to resolve supply conflicts
Own cross functional alignment and setup of Physical and Financial Flows specific for product and country
Execute Operations Commercialization Strategy through regional strategy development and management; ensure regional adherence to CMC Excellence
Lead all aspects of product launch change control records with SCPM hub, owns change control records as necessary
Identify changes and work together with the regional planners for ERP systems setup (such as the creation of sales org, material # and customer #); partner with regional planner to ensure timely setup
Contribute to preparation and review of supply agreements and regulatory documentation
Lead Regional variation management review process to resolve supply strategy for assigned products
Ensure country regulations and requirements are clearly understood and incorporated into the global and regional processes
Ensure compliant execution to meet local regulatory, trade, and quality regulations
Ensure compliance to Service Level Agreements (SLA) with manufacturing sites and distribution hubs
Identify process improvement for efficiencies and opportunities for automation
International and domestic travel might be required; expect less than 10%
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Management professional we seek is a collaborative partner with these qualifications.
Basic Qualifications:
Doctorate degree OR Masters degree and 2 years of Supply Chain/ Customer Service/Operations experience in a GMP and/or Good Distribution Practice regulated industry OR Bachelors degree and 4 years of Supply Chain/Customer Service/Operations experience in a GMP and/or Good Distribution Practice regulated industry OR Associates degree and 10 years of Supply Chain/Customer Service/Operations experience in a GMP and/or Good Distribution Practice regulated industry OR High school diploma/GED and 12 years of Supply Chain/Customer Service/Operations experience in a GMP and/or Good Distribution Practice regulated industry.
Preferred Qualifications:
Fluent in English and Spanish, oral and written
Fluent in Portuguese (a plus)
Bachelors Degree in Business, Supply Chain, or Engineering
Experience working with multiple geographies and cultural backgrounds worldwide
Knowledge of emerging new technologies such as Robotic Process Automation (RPA) and application
Experience with budget planning development and solutions
APICS or equivalent Supply Chain/Operations certification
3 + years of experience in Pharmaceutical product commercialization, Lifecycle Management, Product Launches, Planning
Experience with Regulatory Affairs requirements, Clinical Development and/or International Business, Supply Chain operations
Understanding of marketing principles, competitor practices, and knowledge of commercialization and launches
Experience in project management across departments and geographies
Ability to recognize strategic implications of sophisticated product development activities and lead them cross-functionally
Quick process understanding, insight and visualizing
Strong analytical skills (incl. MS Excel, MS Power Point) and ability to summarize and clearly communicate findings
Able to support multiple products and projects, able to work autonomously and in teams to meet completion date
Relationship builder in which the employers interest prevails
Motivated, persistent, eager to optimize, drive for excellence
Problem solver with high sense of responsibility to achieve results
Strong communication and presentation skills (verbal & written)
Able to breakdown intricate problems and convey clear message and solutions
GMP knowledge and understanding of pharmaceutical regulations
Understanding of Quality and regulatory requirements
Thrive
Some of the vast rewards of working here
As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.
Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
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.
Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.Company info
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