Project Manager (Pharma - NPI Launch Related)

Adaptive HVM; Dublin; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

Adaptive Hvm Limited in Dublin 15 is seeking an senior Project Manager – Pre-Commercial Launch Lead to partner with senior Product Management leaders and drive operational launch strategies for new products across global markets.

You will coordinate cross-functional teams (Supply Chain, Manufacturing, CMC, Quality, Regulatory, Commercial) to ensure launch readiness, manage risks, and onboard new manufacturing sites while maintaining GMP compliance.

Qualifikationen

• 5+ years in biopharmaceuticals or pharma with accountability for high-profile projects, preferably in launch readiness or lifecycle management.
• Strong problem-solving: clarify issues, identify root causes, assess impacts, and recommend actions.
• Ability to manage competing priorities, attention to detail in a complex environment.
• Proven ability to build relationships, influence stakeholders, and align across a global matrix.
• Familiarity with Smartsheet and other project management tools/systems.
• Experience working cross-functionally with RD and Commercial in a matrix setup.
• Excellent presentation and communication skills, both written and verbal.
• Ability to engage with senior Operations management and cross-functionally.
• Understanding of risk management and GMP/regulatory concepts.

Aufgaben

• Coordinate the operational execution of global product launches across cross-functional teams.
• Establish clear actions, owners, timelines and expected outcomes; monitor progress against the integrated launch plan.
• Engage with partners to understand launch expectations, market scope/requirements, and acceleration needs.
• Onboard new manufacturing sites for launches of new molecule entities or product presentations; act as a key coordinator for problem solving.
• Challenge assumptions and ensure solutions consider supply, manufacturing, CMC, Quality, Regulatory, Commercial, Market and Patient implications.
• Proactively manage complex risks using supply chain knowledge to create innovative solutions.
• Ensure GMP compliance and continuous improvement of quality processes within area of responsibility.
• Build strong relationships across the global organization and adapt to diverse cultures.

Kenntnisse

Project management

Cross-functional collaboration

Problem solving

Risk management

Stakeholder management

Regulatory knowledge

Smartsheet

Communication skills

Ausbildung

Science, Engineer or Business Degree

Tools

Smartsheet

Project management tools

Jobbeschreibung

Job Title : Snr Project Manager Pre-Commercial Launch Lead

Location: Dublin 15

Duration : 12 + months

Overview

The Launch Lead sits within the Alexion Product Management Team in Global Supply Chain Strategy and has a critical role in partnering with the Associate Director, Pre-Commercial Launch Lead and the Strategic Product Leads (SPLs) to develop and delivery operational launch strategies. The person in this role will align, lead, collaborate and influence across functional barriers to establish supply chains and execute global product launches of new products and new product presentations.

Our Clients New Product portfolio has grown significantly and they are handling a growing level of complexity with the launches we are leading and this role plays a pivotal part in managing this complexity—including small molecules, biologics, and external partnerships while accelerating launch timelines. The Launch Lead works to ensure that the Global Operations Launch Teams (GOLTs) operate effectively and deliver the operations launch strategy agreed with the Global Program Teams

• Support the Associate Director,in coordinating the operational execution of global product launches.Coordinate activities across cross-functional teams, including Supply Chain, Manufacturing, CMC, Quality, Regulatory, Commercial, Operations and market organisations.
• Establish clear actions, owners, timelines and expected outcomes for agreed launch activities.Monitor progress against the agreed integrated launch plan, identifying slippage, emerging dependencies and potential impacts for review by the Associate Director.
• Engage actively with partners across the business to understand the global launch expectations, market scope/requirements and potential needs for acceleration, ultimately ensuring the timely delivery of launch stock to markets
• Act as Project Manager for the onboarding of new manufacturing sites (internal and external) selected for the launch of new molecule entities or for the launches of new product presentations Act as a key coordinator for operational problem solving across the launch programme.
• Challenge assumptions constructively and ensure that proposed solutions consider supply, manufacturing, CMC, Quality, Regulatory, Commercial, Market and Patient implications.
• Proactively manage complex risks and challenges using supply chain knowledge and network insights to develop innovative solutions.
• Ensure these solutions are embedded and shared across the business
• Build strong relationships across the global organization, displaying cultural awareness and adaptability
• Ensure compliance with GMP and regulatory requirements (including record management) and continuous improvement of quality relevant processes within area of responsibility

Qualifications

• 5+ years working experience in a biopharmaceutical or pharmaceutical company having held accountability for the implementation of high-profile projects, ideally in operational launch readiness or Life Cycle ManagementDemonstrated experience leading through influence and coordinating delivery across cross-functional teams without formal line-management responsibility.
• Strong problem-solving experience, including the ability to clarify complex issues, identify root causes, assess impacts and develop practical recommendations.
• Ability to manage competing priorities, maintain attention to detail and work effectively in a complex and changing environment.
• Demonstrated ability to build relationships, influence stakeholders and create alignment within a global matrix organisation.
• Knowledgeable about Smartsheet and other Project Management tools/systems
• Experience of working cross-functionally with RD and Commercial in a matrixed environment
• Excellent level presentation skills and polished written and oral communication ability
• Ability to engage with senior management in Operations and cross-functionally
• Good understanding of Risk Management
• Strategic thinking, balancing short and long-term priorities

Education

• Science, Engineer or Business Degree required