Global MES Implementation Lead

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We advance science so that we all have more time with the people we love. At Roche, we are committed to delivering greater benefits to patients as part of our 10-year Pharma vision. To achieve this, we are transforming Pharma Technical Operations (PT) through innovative data analytics solutions enabled by the PT Digital and Operational Excellence (PTE) organization.

The global MES program is accountable for developing MES business strategies and the implementation of harmonized Manufacturing Execution Systems (MES) within the entire PT network covering clinical and commercial manufacturing operations.

As the Global MES Deployment Lead, you will be responsible for the extensive, large-scale implementation of MES business processes and systems across multiple pharmaceutical sites, ensuring minimal disruption to supply chains and maintaining operational continuity. This includes managing budgets effectively, ensuring financial resources are allocated efficiently, and costs are kept in line with project goals. Moreover, you will be responsible for maintaining strict compliance with current Good Manufacturing Practices (cGMP) throughout the project, safeguarding product quality and regulatory adherence.

In this pivotal role, you will coordinate complex project activities on multiple sites, facilitate effective communication with key stakeholders, and ensure adherence to the highest quality and compliance standards. Additionally, you will deputize the Global MES Program Lead by offering strategic insights and leading efforts in continuous improvement and optimization for the complex integration of the MES platform.

You will report directly to the global MES Program lead and be part of the global MES core leadership team.

Large-Scale Project Management:

• Lead overall MES deployments from a business and technical perspective.
• Oversee the planning, execution, and coordination of the MES implementation, characterized by its broad scope and high complexity.
• Uphold high-quality standards and regulatory compliance, focusing on risk management strategies to mitigate potential impacts on the supply chain during these extensive system changes.
• Manage budgets (100 Mio+) effectively, ensuring financial resources are allocated efficiently and keep costs in line with project goals.
• Manage interactions with partnering functions like global Design Authorities, global and local steering committees.
• Manage the connection between the platform project and global and local governance bodies.
• Guarantee a seamless transition with minimal impact on ongoing operations.
• Manage, coach and continuously develop the project teams.

Stakeholder and Change Management:

• Collaborate with stakeholders at all levels, including PT senior management, site heads, global and local quality functions, Pharma site services, vendors, IIX, and ITOT.
• Co-lead the global MES sounding board.
• Actively predict future stakeholder and business needs. Manage expectations effectively.
• Lead change management efforts, ensuring smooth transition and adoption of new processes across sites.
• Act as a global primary change agent towards senior management.

Continuous Improvement and Best Practices and Standards:

• Establish and maintain industry best practices and standards for MES platform implementations.
• Define and track key performance indicators (KPIs) to assess the effectiveness of platform implementation.

Deputy Lead “Global MES Program”:

• Provide strategic support and oversight for the MES program.
• Collaborate in high-level planning, decision-making, and problem-solving on MES program level.
• Be a member of the global MES steering committee.

Member of the global MES Program Team:

• Strongly contribute to the continuous evolution of the global MES framework.
• Collaborate on the initiation of new platform projects.

We are currently in search of an individual who possesses exceptional leadership qualities, coupled with a comprehensive background in MES and manufacturing operations. This encompasses both site-specific and overarching network perspectives. The ideal candidate should demonstrate strong change management capabilities and exceptional global communication skills characterized by inclusivity and effectiveness.

The successful applicant will be distinguished by their astute business acumen in the pharmaceutical sector. As an open-minded individual, you should be prepared to constructively challenge conventional methodologies, contributing to the advancement and innovation of our practices. A proven track record of successful partnerships with key senior-level stakeholders is essential. This includes but is not limited to Pharma Technical Leadership Team (PTLT), Site Heads, and Pharma Technical (PTx) stakeholders.

We seek a visionary leader who is prepared to significantly impact our dynamic and evolving environment.

Qualifications:

• Master's Degree in Engineering and/or Business and +5 years of cumulative experience in Life Sciences, medical and/or pharmaceutical groups in a regulated field.
• Extensive knowledge of MES systems, manufacturing processes, and industry-specific regulations (e.g., cGMP, FDA).
• Proven track record in managing significant projects/programs.
• Superb leadership and decision-making skills.
• Excellent communication and stakeholder management abilities.
• Strong understanding of pharmaceutical manufacturing processes and digital enablement of the end-to-end processes.
• Ability to travel as required.

Competencies:

• Strategic Thinking: Ability to see the big picture and orchestrate changes across multiple sites.
• Analytical Skills: Strong capability to analyze processes and identify areas for improvement.
• Influencing Skills: Ability to persuade and align diverse senior stakeholder groups within the network.
• Problem-Solving: Skilled in identifying challenges and proactively developing solutions.
• Adaptability: Comfortable with navigating a dynamic and changing environment.
• Decision Making: Sound judgment in synthesizing data and information to make timely decisions.

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