Regional Operations Manager

As Amgen expands globally, the Regional Operations Manager is a key position in implementing the Intercontinental-Latin-America (ICON-LATAM) Region's 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 Intercontinental (ICON) Latin America commercialization strategy for assigned product(s)
• Lead Regional Operations Team Meetings to manage launches and product lifecycle events
• Lead cross functional meetings that support the Regional commercialization plans
• Ensure launch and variations strategy and plans are in place and clearly communicated
• Represent the region and country at the Product Delivery Team (PDT); attend PST meetings
• Participate in Joint ventures and partnership management activities for assigned products
• Represent Operations and Supply chain for the region and countries at the Global, Regional, site and/or country meetings as needed
• Communicate region's decisions, 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 leveraging Network Knowledge sharing forums
• Develop regional network supply strategy with Global Supply Chain and Sites
• Ensure undisrupted patient supply, supply risk assessment and mitigation plans throughout the Life cycle management of products
• Support Demand and Supply Alignment activities for assigned product/market
• Represent the supply network and work with region's cross functional team (Commercial, Finance, Regulatory Affairs, Quality) to develop compliant product supply strategy for the planning horizon
• Represent the region commercial plan 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
• Oversee product launch change control records with SCPM hub; work with country planners to develop change control records strategy as necessary for country readiness
• Identify changes and work 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 as needed
• Lead Regional variation management review process to determine supply strategy for assigned products
• Ensure country regulations and requirements are clear and incorporated into the global process
• Ensure compliant execution to meet local regulatory, trade, and quality regulations
• Ensure compliance to Service Level Agreements (SLA) with manufacturing sites
• Identify process improvement for efficiencies and opportunities for automation
• International and domestic travel might be required; expect less than 10%

BASIC QUALIFICATIONS:

Doctorate degree

OR

Master's degree and 2 years of Supply Chain / Customer Service / Operations experience in a GMP and/or Good Distribution Practice regulated industry experience

OR

Bachelor's degree and 4 years of Supply Chain / Customer Service / Operations experience in a GMP and/or Good Distribution Practice regulated industry experience

OR

Associate's degree and 10 years of Supply Chain / Customer Service / Operations experience in a GMP and/or Good Distribution Practice regulated industry experience

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 experience

PREFERRED QUALIFICATIONS

• Fluent in English and Spanish, oral and written
• Fluent in Portuguese
• Bachelor's 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, Life Cycle Management, Product Launches, Planning
• Experience with Regulatory Affairs requirements, Clinical Development and/or International Business, Supply Chain operations
• Understanding of marketing principles and competitor practices
• Understanding of commercialization and launches
• Experience in project management across departments and geographies
• Ability to recognize strategic implications of complex product development activities and manage 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
• Independent self-starter, able to support multiple products and projects, able to work autonomously, under pressure and in teams
• Relationship builder in which the employer's 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 complex problems and convey clear message and solutions
• GMP knowledge and understanding of pharmaceutical regulations
• Understanding of Quality and regulatory requirements

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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.

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.