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:
The Site Data Leader 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 Leader ensures 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 GDP and 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. The Site Data Leader is responsible for ensuring the education and continuous knowledge on data integrity and data management for distribution. This role is also responsible for adherence to data management standards and to ensure consistency and consumability of data to drive process improvements. This role ensures compliance and inspection readiness of the data integrity and data management program at the site level. The Site Data Leader is responsible for ensuring the site’s data integrity training program facilitates the sustainment of its data integrity continuous improvement journey.
Responsibilities:
Develop a comprehensive and integrated data integrity and data management program.
Facilitate the Site Data Lead Team, including integration of all functions in global logistics (GLX).
Coordinate activities with each function and manage data integrity staff for larger locations (e.g. NALO).
Partner with global and 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.
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).
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.
Lead initiatives related to data integrity and data management for GMP information at the NALO site:
Own site actions associated with the enterprise data management and integrity initiatives.
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.
Own the responsibility for enhancing and sustaining data management and integrity principles throughout the data lifecycle.
Ensure continuous professional development, education, training and knowledge transfer of data integrity and data management principles:
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.
Ensure compliance and inspection readiness of the data integrity and data management program at the site level:
Coach individuals on inspection interactions.
Lead preparation of data integrity and data management topics for audit and inspection readiness.
Network with other sites and central groups to understand external and company trends and develop internal plan.
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.
Act as site liaison and representative for the data integrity and data management program.
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.
Other responsibilities may include:
Participate in Self-Inspections
LQS/GQS education and implementation
Quality Plan
NALO compliance to the Global Records and Information Management Retention Schedule
GMP Libraries at any location
Basic Qualifications:
Bachelor’s degree or higher in the sciences, engineering, or related field
5+ years of experience in GMP operations
Additional Skills/Preferences:
Strong Influencing Skills and interpersonal and teamwork skills
Strong self-management and organizational skills
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.
Ability to communicate effectively with all levels and functions in the organization.
Ability to work on multiple concurrent project initiatives.
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.
Speak up with ideas as well as concerns and ensure the psychological safety of others.
Strong collaboration with colleagues at all levels.
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.
Additional Information:
Available to travel (domestic and international) on an average of