Associate Director - Operational Readiness

Eli Lilly and Company; Katwijk; On-site; EUR 120,000 - 180,000; Full time

Job summary

Lilly, a global pharmaceutical company, invites applications for the Associate Director – Operational Readiness role at its Katwijk, Netherlands site. The role leads an integrated startup plan and collaborates with multiple project teams to ensure timely, safe, and efficient facility readiness and startup.

Successful candidates will bring extensive manufacturing leadership experience, expertise in cGMPs, and a track record of delivering complex pharmaceutical projects on schedule and within

Qualifications

• Bachelor's degree (or equivalent) in Engineering/Science and experience in a functional or operational leadership role within the pharmaceutical industry

Responsibilities

• Identify pre-manufacturing program elements required for operational readiness.
• Develop an integrated startup plan with key linkages, durations, and resources.
• Serve as key interface between the GFD project team and site end users to align priorities.

Education

Bachelor's degree in Engineering/Science

Tools

Trackwise

Veeva

QualityDocs

Kneat

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Eli Lilly is investing €2.6 billion in a new state-of-the-art manufacturing facility in Katwijk, Netherlands. This facility will produce oral medicines for cardiometabolic health, neuroscience, oncology, and immunology, incorporating next-generation manufacturing technologies including dock-to-dock automation, paperless manufacturing, and process analytical technology while achieving carbon neutrality and zero waste to landfills.

Role Overview

The Associate Director – Operational Readiness is a key site leader who will ensure a comprehensive, coherent, and clear integrated project plan is developed and managed to successfully bring the manufacturing facility to a state of operational readiness. This role will work closely with various project delivery Project Managers and the site Lead Team to ensure integration of all project workstream deliverables. The role will report through site operations and will be a key leader during operational readiness planning and site startup. The Associate Director – Operational Readiness will ensure clear communications and alignment between the GFD project team and all other relevant stakeholders (e.g. Ops, TSMS, Engineering, QA, QCL, Maintenance, Logistics, IT, etc.); understand and work through complex linkages related to the overall project scope; and work through barriers that could impact safe, on time, and right first time facility startup. The Associate Director – Operational Readiness will also have responsibility for the site Operational Excellence group, which will establish Lean principles and an Operational Excellence framework for the site.

Key Responsibilities

• With input from all cross functional stakeholders, identify all the relevant pre-manufacturing program elements necessary to be in place to support overall facility operational readiness.
• Work with the GFD project team and site functional representatives to develop an integrated start up plan reflective of key linkages, interdependencies, durations, resource requirements, and any other relevant factors.
• Be a key interface point between the GFD project and the site end users to ensure the right priorities are communicated & understood across multiple stakeholders.
• Lead a cross functional team, creating and implementing an integrated plan. Create strong morale and foster open dialogue.
• Partner with relevant stakeholders to ensure clear scope alignment and resulting goals and timelines for the project are met.
• Facilitate decision making within the team under tight deadlines.
• Effectively communicate and manage internal and external stakeholders.
• Proactively manage issues, proposing and implementing plans to resolve as needed.
• Forecast resource needs across the integrated plan and anticipate and resolve any projected resource issues before they impact project delivery.
• Provide relevant metrics to appropriate site and network governance forums (Site Lead Team, Executive Project Steering Team, etc).
• Leverage lean management best practices to align the team's tiered meetings, communication, and escalation process to ensure speed in decision making and adaptation to changes.
• Establish an operational excellence culture and embed Lean principles as the site governance processes are built.

Basic Qualifications

• Minimum of a Bachelor's degree (or equivalent) in a relevant discipline (Engineering/Science) and experience in a functional or operational leadership role within the pharmaceutical industry
• 6+ years in manufacturing - OSD/SDD experience preferred
• Previous experience requiring knowledge and application of cGMPs in manufacturing operations.
• Demonstrated track record of successfully developing, managing and executing projects from start to finish on time and within budget with high performance standards that ensure customer satisfaction.

Additional Skills/ Preferences

• Demonstrated ability to manage in a dynamic environment. Flexibility to adjust quickly and effectively to frequent change and altered priorities.
• Demonstrated ability to input and influence decision making for complex technical issues.
• Excellent self-management/organizational skills; manage workload, set team priorities and adjust.
• Ability to interact with multiple functions (such as Technical Services, Engineering, Quality, QC, IT, Operations, etc.) and combine work streams into an integrated schedule. Demonstrated ability to influence peers and business partners.
• Strong interpersonal and teambuilding skills; able to develop effective teamwork between team members with diverse interpersonal styles.
• cGMP standards and FDA (or equivalent regulatory agency) guidelines for production.
• Proficient in continuous improvement methodologies and mindset – lean, six sigma, etc.
• Documentation, deviation and change management systems (e.g., Trackwise, Veeva, QualityDocs, Kneat).

Additional Information

• This position starts with a 12-month contract, with the intention of offering a permanent contract based on mutual fit./ "Dienstverband: tijdelijk met uitzicht op vast"\
• On-site presence required with flexibility per site policy.
• Travels often, as required to support network and project activities.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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