Operations Lead Manager

Operations Lead Manager

Requirements

• 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 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

Responsibilities

• 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 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 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

Preferred Qualifications

• Fluent in English and Spanish, oral and written
• Fluent in Portuguese a plus
• 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