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Quality Control Data Integrity Consultant

Indianapolis, Indiana

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Req ID R-3506 Title Quality Control Data Integrity Consultant City Indianapolis State / Province Indiana Country United States

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.

The QC Data Integrity Consultant is accountable for the data integrity program across all labs within Indianapolis Parenteral Manufacturing. They are responsible for ensuring the labs have a comprehensive and integrated data integrity and data management program in place and leads initiatives related to data integrity and data management for GMP information for all forms of data (electronic data, manual data), systems (integrated, stand-alone) and processes (testing, review/approval and management of data). The QC Data Integrity Consultant is responsible for establishing the data management roadmap, ensuring the education and continuous knowledge on data integrity and data management across the QC labs. The QC Data Integrity Consultant is also responsible to ensure compliance and inspection readiness of the data integrity and data management program at the site level.

Education Requirement

  • BSc or MSc in scientific or technical degree: chemistry, biology, engineering or equivalent scientific/technical degree

Basic Qualifications

  • 5+ years of experience in a pharmaceutical industry

Additional Preferences

  • Good knowledge of cGMP, external Regulations and CSV requirements
  • Strong Influencing Skills and interpersonal and teamwork skills
  • Strong self management and organizational skills
  • Demonstrated successful leadership of cross-functional teams and project management experience
  • Strong experience managing regulatory inspections

Key Objectives/Deliverables

  • Develop a comprehensive and integrated data integrity and data management program:
  • Ensuring compliance with all forms of data (electronic data, manual data), systems (integrated and stand alone) and processes.
  • Assessing the process to purchase new equipment to ensure all data integrity requirements are met as part of the procurement process.
  • Establish linkages across other labs within the QC network to determine best practices.
  • To ensure that the labs have an integrated quality system with regards to data management and data integrity that covers, business processes, GMP procedures and standards, governance processes, etc.
  • Understand the various Process Workflow and Data Lifecycles within the lab environment.
  • Develop a strategy to automate the data workflows.
  • Lead programs and initiatives related to data integrity and data management for GMP information across the labs:
  • For all forms of data (electronic data, manual data)
  • Systems (integrated, stand alone)
  • Processes (testing, review/approval and management of data).
  • To develop a comprehensive continuous improvement roadmap to ensure the labs keeps up to date with regulatory expectations, industry best practices, etc….
  • To ensure continuous professional development, education, training and knowledge transfer of data integrity and data management principles
  • Develop, establish and chair governance process across the labs and at a site level.
  • Understand the technical expectations associated with data integrity and be able to translate that into a defined process.
  • To ensure compliance and inspection readiness of the data integrity and data management program across the labs.
  • 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

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.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-3506.

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.

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