Senior Associate - QA Data

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.

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

This role collaborates with QA Compliance leadership and Site Data Leader to ensure that the Site Data Integrity and Data Management Program has the appropriate standards, processes, organization, and governance necessary for its ongoing effectiveness and provides quality oversight to the Site Data Management Program. This role will partner with functional area Data Management and Data Integrity leads to anticipate and resolve key Data Integrity issues while driving solutions that impact the site and align with corporate objectives and initiatives.

This role will leverage a deep understanding of GMP data flows (electronic and paper), the application of Data Integrity principles in MFG / FUME / Lab processes, and Computer System Validation methodologies to ensure regulatory compliance, consistency, and sustainment for Data Integrity (DI) related activities across GMP areas and collaborates ensuring the site's Data Integrity Training Program facilitates the sustainment of its Data Integrity continuous improvement journey. This position collaborates with QA Compliance leadership and site Data Leader / Champion to ensure that the Data Management Program has the appropriate standards, processes, organization, and governance necessary for its ongoing effectiveness.

Key Objectives / Deliverables:

• Responsible for maintaining a safe work environment, leading safety initiatives, and working safely, and accountable for supporting all HSE Corporate and Site Goals.
• Own the responsibility for enhancing and sustaining Quality and Data Integrity principles into computer system lifecycle processes working in collaboration with QA Compliance leadership, Site Data Leader, and Global Computer Systems Quality Assurance (CSQA).
• Ensure DI compliance at the site and implement DI improvement plans.
• Participate in the design and delivery of learning opportunities for personnel with the purpose of strengthening the Quality Culture as it relates to DI (leveraging the network of functional DI SMEs and DI Champions). Provide training, coaching, feedback, and mentoring to personnel on DI principles and regulations.
• Serve as Site Quality Representative on global Data Integrity / Data Management-related forums, providing feedback to the site for opportunities or concerns; participates on site Data Lead team and other data management related governance instances; and SME for DI-related inquiries and trainings.
• Ensure completion and maintenance of Data Flow Maps to identify DI risks and define mitigation strategies.
• Ensure programs are in place to facilitate and support DI improvements to documents, systems, and processes (e.g., audit trail reviews, user access, walk-throughs, Site Self Inspection).
• Communicate DI-related KPIs / metrics and DI deviation trends to the Data Lead Team to highlight areas of concern and opportunities.
• Ensure Data Integrity readiness for regulatory authority inspections and effectively represent the company during regulatory audits through interaction / discussion with regulatory officials related to DI expertise in areas as necessary.
• Ensure compliance with applicable Lilly global standards and regulatory guidelines and collaborate on overall inspection readiness of the site.
• Work with functional area Data Management and Data Integrity leads to ensure the ongoing development and effectiveness of the site Data Integrity Training Program in order to continuously improve data integrity and data management knowledge base and understanding.
• Participate in data 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.
• 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.

Basic Qualifications

• Bachelor's degree or higher in a STEM discipline
• Minimum of 3 years of experience in GMP operations within the Biopharmaceutical industry

Additional Preferences:

• Demonstrated relevant experience in a GMP facility
• Proficiency with IT systems development life cycle
• Proficiency with Computer Systems Validation (CSV) and demonstrated ability to right-size validation based upon risk
• Proficient with computer systems including Microsoft Office, EDMS, SQL, TrackWise, SAP, etc.
• Demonstrated strong communication and interpersonal interaction skills, and ability to influence others and collaborate
• 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 of and functions in the organization.
• Ability to work on multiple concurrent project initiatives.
• Effective problem-solving and analytical skills to resolve operational problems.
• Excellent written and verbal communication skills.
• Ability to build relationships across dimensions of difference, ask questions, and invite others to contribute.
• Demonstrated business acumen.
• Speak up with ideas, concerns, and to ensure 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.
• Demonstrate courage and integrity.
• Demonstrated success in influencing without authority.
• Ability to take initiative, be assertive, lead by example, and build high-quality relationships.
• Highly flexible, adapting to changes in priorities, requirements, and processes is required.

Other Information:

• May be required to support off-shift activities related to operational issues.
• Position located in Indianapolis Parenteral Manufacturing, Indianapolis, IN. Some allergens are present in the Parenteral Plant. Mobility requirements and exposure to allergens should be considered when applying for this position.

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 ( [email protected] ) 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.

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 (subject to applicable law).

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