Regional Operations Lead Manager

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Regional Operations Lead Manager

What You Will Do

Lets do this! Lets change the world! As Amgen expands globally, the Regional Operations Manager is a key position in implementing the Latin-America-Canada (LACAN) 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 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 regions 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 un-disrupted 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 regions 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%
  
  
  

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual 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 experience OR
• Bachelors degree and 4 years of Supply Chain / Customer Service / Operations experience in a GMP and/or Good Distribution Practice regulated industry experience OR
• Associates degree and 8 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 10 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 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, 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 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 complex problems and convey clear message and solutions
• GMP knowledge and understanding of pharmaceutical regulations
• Understanding of Quality and regulatory requirements
  
  
  

What You Can Expect From 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, well 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 and make a lasting impact with the Amgen team.

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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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.