Sr. Associate – Quality Data Management

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:

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.

Responsibilities:

The Associate – Quality Data Management supports the Data Management Program within the Indianapolis Device Assembly and Packaging (IDAP) site. This includes but is not limited to data integrity. This position is an advocate for data management across the site, providing Quality oversight for data management activities and directly supporting the Site Data Leader.  The Associate – Quality Data Management will partner with the Site Data Leader and functional area data experts to resolve key data management and integrity issues and advance data management standards to ensure data consistency and drive process improvements. 

Provide Quality support of the integrated data integrity and data management program:

• Ensure compliance for all forms of data (electronic data, manual data), systems (integrated, stand-alone), areas (production and support areas/processes), processes (manufacturing, review/approval, and management of data).

• Perform gap assessments of the quality system with regards to data management and data integrity that covers, business processes, GMP procedures and standards, governance processes, etc.

• Partner with the Site Data Leader to ensure data integrity initiatives are appropriately supported and resourced by Quality.

• Support data integrity improvements to documents, systems, and processes (e.g., audit trail reviews, user access, walk-throughs).

• Participate in data management and integrity assessments of current-state practices, procedures and system functionality, including but not limited to physical and logical security, Electronic Records/Electronic Signatures (ER/ES), audit trails, data criticality, non-terminal data, data flow mapping, records/data backup, archive and retention, computer system validation, infrastructure qualification, investigation, and training programs.

• Partner with functional site data subject matter experts (SMEs) to ensure that data management actions are completed in accordance with established plan.

Support compliance initiatives related to data integrity and data management for GMP information at the IDAP site:

• Own actions associated with the site data management and integrity initiatives.

• Monitor site data management metrics including tracking and reporting of data integrity action plan status to the Site Data Lead Team.

• Keep up to date with regulatory expectations, industry best practices, external/internal trends, etc. of data management and provide coaching to the site.

• Lead preparation of data integrity and data management topics for audit and inspection readiness.

• Ensure compliance with applicable Lilly global standards and regulatory guidelines.

• Consult on data integrity investigations and CAPA development.

Support continuous professional development, education, training and knowledge transfer of data integrity and data management principles:

• Participate in the design and delivery of training for personnel at the site with the purpose of strengthening the Quality Culture as it relates to data management and integrity.  

• Provides coaching, feedback and mentoring to personnel on data management and integrity principles and regulations.

Basic Requirements:

• Bachelor’s degree or higher in the sciences, engineering, or related field (or equivalent work experience)

• 5+ years of experience in cGMP operations

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

• Good knowledge of cGMP, external Regulations and CSV requirements

• Strong Influencing Skills and interpersonal and teamwork skills

• Strong self-management and organizational skills

• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

Additional Skills/Preferences:

• Experience in Quality Assurance, Quality Control, Operations, Engineering or Technical Services.

Additional Information:

• Some travel (domestic and international) may be required.

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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