Associate Director – Site Data Integrity and Computer System Validation Lead

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.

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.

Position Overview:

The Site Data Leader will have primary responsibility for data management activities within the Lilly Kenosha County (LKC) site. The Site Data Leader is an advocate for data management across the manufacturing site and chairs the site data lead team.

The Site Data Leader ensures a robust Data Integrity Program exists and is maintained 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. The Associate Director, Quality Assurance, will also provide computer system quality assurance oversight during the start-up and routine operation of the Lilly Kenosha County site. In addition, this role will transition to a site-based data management and analytics leader role for routine production. 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.

The Site Data Leader is responsible for ensuring education and continuous knowledge on data integrity and data management at the site.  This role influences improving data management standards 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. The Site Data Leader reports to the Site Quality Leader and has dotted-line accountability to Global Data Management leadership. This is an individual contributor role with responsibility for technical leadership, as well as project management.

Responsibilities:

The Site Data Leader will have primary responsibility for data management activities within the Lilly Kenosha County (LKC) site. The Site Data Leader is an advocate for data management across the manufacturing site and chairs the site data lead team.

The Site Data Leader ensures a robust Data Integrity Program exists and is maintained 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. The Associate Director, Quality Assurance, will also provide computer system quality assurance oversight during the start-up and routine operation of the Lilly Kenosha County site. In addition, this role will transition to a site-based data management and analytics leader role for routine production. 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.

The Site Data Leader is responsible for ensuring the education and continuous knowledge on data integrity and data management at the site.  This role influences improving data management standards 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. The Site Data Leader reports to the Site Quality Leader and has dotted-line accountability to Global Data Management leadership. This is an individual contributor role with responsibility for technical leadership, as well as project management.

Key Objectives/Deliverables

Develop and maintain a comprehensive and integrated data integrity and data management program:

• Facilitate the Site Data Lead Team

• Partner with global and site leadership to ensure data integrity initiatives are given appropriate priority and cross functional 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 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 including the transition from paper-based processes to digitized solutions.

• Own the responsibility for enhancing and sustaining data management and integrity principles throughout the data lifecycle.

• Own the development, maintenance, and be accountable for the implementation of the site Data Integrity Strategy

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 improvement plans.

• 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 global organization 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.

Act as the Computer systems validation quality assurance project lead, working with Global Facility Delivery and Lilly project staff to complete the detailed design of the assigned areas employing QbD and QRM principals and ensuring the integration of Global Quality System requirements into the design. Responsibilities include: 

• Consult with Network and Global quality groups including the Global Quality Systems, Information Systems Quality, and Global Data Management as required to ensure consistent and compliant approach is executed during the project and startup phase 

• Provide technical and quality review and approval of project computer system documents to ensure compliance with Lilly Global Quality Standards as well as project and local quality procedures, including review of test cases, test execution, discrepancy resolution, etc.  

• Work with the Associate Director, Quality - Compliance, to support the development of the vision and strategy for the overall site quality operation with focus on the CSQA topics 

• Support the site organization in building technical capability, for a diverse cross-functional staff in Quality, the project team, and area process teams, including mentoring of new Quality and other project staff 

• Lead project initiatives needed in support of the project and Quality function 

• Resolve or escalate any compliance issues to the project, site, and Quality Management 

• Participate in self-led inspections and provide support during internal/external regulatory inspections

• Ensure data integrity by design

• Leverage technology to ensure data digitalization and standardization where appropriate

• Design, replicate and employ analytics and advanced analytics for competitive advantage within the site

Basic Requirements:

• Bachelor's degree required; engineering or computer science-related field preferred

• Minimum 5 years working in the pharmaceutical or medical device industry in QA roles 

• Minimum 3 years of experience in Computer System Quality Assurance/Computer System Validation

• Minimum 3 years of experience with data analytics including advanced analytics  

Additional Skills/Preferences:

• Demonstrated successful leadership of cross-functional teams and project management experience

• Demonstrated proficiency with GMP computer systems validation including regulations governing them

• Demonstrated knowledge and application of data integrity regulatory guidance

• Proven ability to apply analytics and advanced analytics for competitive advantage within a manufacturing operation 

• Demonstrated strong oral and written communication

• Strong self-management and organizational skills

• Demonstrated strong interpersonal interaction skills and ability to influence cross-functional organizations

• Demonstrated strong technical writing skills 

• Demonstrated strong problem-solving and decision-making skills

• Has previous facility or area start up experience 

• Has previous qualification and validation experience (process automation and/or IT systems) 

• Has previous Six Sigma Green Belt or Lean Training/Experience 

• Has CQA certification from the American Society for Quality (ASQ) - preferable

Additional Information:

• Position requires onsite presence with flex time available

• Ability to work overtime as required

• Ability to travel up to 10%

This job description is intended to provide a general overview of the job requirements at the time it was prepared.  The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes.  As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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