At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Organization Overview:
Lilly is currently constructing a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland. This facility will be Lilly’s most technically advanced manufacturing site and will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and increased productivity and process performance. This is a unique opportunity to be a part of the leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup of GMP operations.
The QC Systems and Compliance team provides support to the QC function owning cross lab programs such as electronic systems qualification and ongoing support, equipment qualification and management program, personnel qualification, compendial updates, inspection readiness and ownership of shared lab equipment.
Responsibilities:
Provides leadership, direction and governance for the Limerick QC Systems and Compliance team to ensure delivery of operational and scientific excellence.
Ownership of QC programs supporting all labs such as equipment and electronic systems, personnel qualification and inspection readiness.
Technical expertise in regulatory requirement related to QC operations.
In depth understanding of operations in QC testing including esystems and data integrity requirements.
Recruits and develops team members to deliver scientific excellence.
Develops future leaders within the function and facility.
Has a business management, site management and team management role (consistent with the Associate Director position across site)
Specifically, during the startup phase of the Limerick site (2023 to 2025) leadership will be expected to be collaborative, inclusive, energetic and support the broader Limerick team to:
Provide technical guidance to team members and build technical capability within the team.
Build the organization with the necessary capability, capacity and culture to operate this facility to the highest standards of excellence
Develop and implement the systems and processes needed to run the site, leveraging existing Lilly knowledge and practices where necessary, but also incorporating external experiences and learning.
Ensure regulatory compliance and operational excellence by supporting lean principles and a Digitally Native approach
Support the project team as they deliver the facility to the site team, by providing feedback and support on decisions and strategies etc. Collaborate with them to ensure the right decisions are made to meet project deliverables and longer-term strategic goals for the site.
Basic Requirements:
BSc (Hons), MSc, or PhD in Chemistry, Biochemistry, Microbiology ore related disciplines.
Minimum 8 years working in a GMP pharmaceutical/ biologics laboratory, environment
Minimum of 2 years’ experience in leadership of a cross functional team
Additional Skills/Preferences:
Business Knowledge: High performance in delivery of their work. Looks at better, simpler ways, takes initiative and will run proactively with actions. Demonstrated self-management, prioritisation and organisational skills.
Learning agility and Curiosity: High learning agility and flexibility and ability to deal with ambiguity and uncertainty. Demonstrated ability to identify and prioritize problems, develop and implement solutions.
Positive Influence: Demonstrated ability to address issues as they arise and take action. Trusted in the team to follow through on actions. Is interested in own performance and seeks feedback to improve.
Relationship Builder: Demonstrated ability to establish and maintain key relationships across all levels in the organisation.
Ability to lead people: Demonstrated ability to lead and motivate in a team environment. Demonstrated ability to influence peers and across functions.
Communication: Demonstrated strong communication skills, written and oral in 1:1 and group situations.
Decision Making: Demonstrated ability to be decisive and make well informed decisions for the benefit of the team. Demonstrated ability to collate required information and ask the appropriate questions of peers to get to the best solution.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
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