Lilly QC Systems Lead in United States
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 35,000 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.
Lilly manufacturing sites worldwide are introducing a number of next generation technologies and digital capabilities that will allow them to become the predictive and adaptive “digital plants of the future”. With that innovation in mind, Lilly is designing and building a new state of the art parenteral, device assembly, and packaging facility located at the Research Triangle Park (RTP) in North Carolina. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and quality system from the ground up.
Manufacturing and Quality Information and Digital Services (MQ IDS) supports manufacturing operational excellence and productivity efforts through utilization of information and technology. MQ IDS strives to enable the making of medicine “with safety first and quality always”.
This IDS Quality Control Lead position at Research Triangle Park (RTP) will partner with the quality control functional area to identify opportunities and lead the implementation/support of digital solutions that support the RTP manufacturing site.
· Develop application knowledge and business context
· Be an expert and resource in the business use of IDS applications within the quality control laboratory
· Accurately translate business processes into technical terms and vice versa
· Leverage knowledge of the business, IDS portfolio, and architectural standards to develop and quantify business cases to provide input to the IDS roadmap and to measure the value gained from the implementation of solutions
· Build and maintain awareness and knowledge of regulatory, legal, or quality requirements impacting the quality control laboratory, and ensure that solution requirements comply
· Lead the delivery and support of digital solutions to start up new quality control lab
· Work with global system teams to understand and implement local responsibilities for system delivery (i.e. validation plans, standard operating procedures, training, etc.)
· Work with the business to identify and capture new opportunities, improve processes, and optimize the value IDS can provide
· Effectively influence the business to drive value and to implement the appropriate digital solutions, and challenge different levels of the organization
· Provide status reporting and manage issue escalations
· Produce and maintain project and validation documentation
· Ensure systems remain in a validated state and manage their lifecycle through releases, recapitalization, and retirement
· Ensure the incident, problem, configuration, and change/release management are all accomplished in alignment with and understanding of business need
· Bachelor of Science Degree in IT, Chemistry, Pharmacy, Science, Engineering, or related field
· At least 3 years of relevant work experience in information technology, engineering, computer system validation, quality control support or related areas
· Prior work experience working in pharma or other GMP/GLP setting
· Strong working knowledge of quality control laboratory IDS systems (i.e. Empower, SmartLab, Darwin, etc.)
· Solid knowledge of Computer System Validation process
· Demonstrated ability to analyze, anticipate, and resolve complex issues (technical, operational, or business-related) through sound problem-solving skills
· Effectively prioritize and escalate issues
· Demonstrated ability to influence without authority
· Demonstrated learning agility and curiosity
· Demonstrated ability to understand manufacturing business processes and convert into IT requirements/solutions
· Demonstrated ability to evaluate, facilitate, and drive towards risk-based decision making
· Desire and ability to communicate using a variety of methods in diverse forums
Lilly is an EEO/Affirmative Action Employer and 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.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company. If you would like to request an accommodation for medical or religious reasons, you may do so at email@example.com.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!