Eli Lilly And Company
Site Data Quality Lead (Finance)
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 39,000 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.
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Lilly is a fortune 500 company in operation for over 140 years creating high-quality medicines for our patients while living our company values of Integrity, Excellence, and Respect for People in everything that we do.
Lilly is designing and building a new state of the art Parenteral, Device, and Packaging Assembly Facility in Raleigh-Durham North Carolina. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up.
Position Brand Description:
The Site Data Lead will have primary responsibility for data management activities within the site. This includes data integrity. He/she will be an advocate for data management across the manufacturing site and will chair the site data lead team. The Site Data Lead will ensure that a robust Data Integrity Program exists within the site providing strong project management leadership to advance the site's agenda. This requires interface with the M&Q Data Management organization, serving as a global data management subject matter expert to facilitate and drive improvements in M&Q data-related corporate quality standards, business processes, organizational design, and governance necessary for ongoing data integrity effectiveness. This role will partner with functional area data experts to anticipate and resolve key data management and integrity issues while driving solutions that impact the site and align with corporate objectives. This role will leverage a deep understanding of GMP data flows (electronic and paper), the application of data management and integrity principles in operational processes, and Computer System Validation methodologies to ensure regulatory compliance, consistency, and sustainment. This role will be responsible for ensuring the site's data integrity training program facilitates the sustainment of its data integrity continuous improvement journey. The Site Data Leader will also be responsible for advancing data management standards to ensure consistency and consumability of data to drive process improvements.
Key Objectives/Deliverables:
Support project activities in development and execution of data integrity deliverables for all direct impact systems and processes.
Own site actions associated with enterprise data management and integrity initiatives.
Facilitate the Site Data Lead Team.
Maintain site data management metrics and track status of the data integrity action plans; Report the status to the Site Data Lead Team.
Provide direction on the operationalization of the data management action plan.
Partner with site leadership to ensure data integrity initiatives are given appropriate priority and resources.
Partner with functional site data subject matter experts (SMEs) to ensure that data management actions are completed in accordance with established plan.
Own the responsibility for enhancing and sustaining data management and integrity principles throughout the data lifecycle.
Participate in the design and delivery of learning opportunities for personnel with the purpose of strengthening the global M&Q Quality Culture as it relates to data management and integrity. Provide training, coaching, feedback and mentoring to personnel on data management and integrity principles and regulations.
Serve as the site liaison with the Global Data Management organization forming the data community of practice; provide feedback to the site for opportunities or concerns.
Serve as a global data management subject matter expert to facilitate and drive improvements in M&Q data-related corporate quality standards, business processes, organizational design, and governance necessary for ongoing data integrity effectiveness. Utilize site data management expertise to solve problems both locally and across global M&Q.
Make decisions as part of the global data community of practice to drive standardization of data and harmonization of business processes across M&Q; Influence global M&Q implementation.
Ensure completion and maintenance of Data Flow Maps as applicable to identify data integrity risks and define mitigation strategies.
Ensure programs are in place to facilitate and support data integrity improvements to documents, systems and processes (e.g. audit trail reviews, user access, walk-throughs, Site Self Inspection).
Ensure inspection readiness for regulatory authority inspections and effectively represent the company during regulatory audits through interaction/discussion with regulatory officials related to data integrity expertise in areas as necessary.
Ensure compliance with applicable Lilly global standards and regulatory guidelines.
Participate in data management and integrity assessments of current-state practices, procedures, system functionality, including but not limited to physical and logical security, Electronic Records/Electronic Signatures (ER/ES), audit trails, data mapping, records/data backup, archive and retention, computer system validation, infrastructure qualification, investigation, and training programs.
Implement defined data standards (e.g., data structure, metadata) and usage guidelines as information passes through multiple systems/functions and ensure processes are in place to manage the data throughout its lifecycle.
Implement data strategy actions (e.g., digitization, contextualization, visualization) to enable appropriate use of data at the appropriate time to enable robust decision making, drive productivity, and facilitate continuous improvement.
Support and abide by applicable Lilly policies as indicated in the Lilly Red Book and other company policies and procedures. All corporate compliance training requirements must be met as required and defined.
Additional Skills/Preferences:
Demonstrated proficiency in planning and the ability to carry out tasks with a high degree of independence as well as being able to work in a team environment.
Strong project management and organizational skills are a must.
Demonstrated ability to interpret and apply standards to different situations by understanding site needs and applying good problem-solving skills.
Demonstrated ability to write technical documents, develop business presentations and effectively communicate concepts to a wide range of personnel including senior leadership.
Ability to influence and contribute to strategy and agenda in the area of data integrity.
Strong knowledge and technical expertise in areas of cGMPs, production practices, and quality systems.
Recognized understanding of regulations governing data integrity.
Ability to build relationships across dimensions of difference, ask questions & invite others to contribute.
Demonstrated business acumen.
Speak up with ideas as well as concerns and ensure the psychological safety of others.
Demonstrated learning agility and ability to think creatively; try new ideas and apply learnings.
Highly motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues.
Strong collaboration with colleagues at all levels.
Demonstrated courage & integrity.
Demonstrated success in influencing without authority.
Ability to take initiative, to be assertive, to lead by example and to build high-quality relationships.
Highly flexible, adapting to changes in priorities, requirements and processes is required.
Education Requirements:
Bachelor's degree or higher in the sciences, engineering, or related field. (or equivalent work experience)
Experience/Knowledge:
Minimum of 5 years of experience in GMP operations
Understanding and working knowledge of domestic and international data integrity regulations and other policies/regulations as applicable.
Understanding of IT system design, controls, and usage.
Working knowledge of laboratory, operations, and maintenance processes including automation.
Ability to communicate effectively with all levels and functions in the organization.
Ability to work on multiple concurrent project initiatives.
Other Information:
Available to travel (domestic and international) on an average of <10%
Aspects such as site size, data complexity, FDA-regulated status, regulatory landscape, commercialization agenda, product launch focus, and product portfolio factored into position leveling.
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.
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.