This job listing has expired and the position may no longer be open for hire.

QA - Data and QMS System Steward at Eli Lilly And Company in Durham, North Carolina

Posted in General Business 30+ days ago.

Type: Full-Time





Job Description:

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.

Company Overview:

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. #WeAreLilly

Position Brand Description:

Lilly is a fortune 500 company in operation for over 140 years creating high-quality medicines for our patients while living our company values of Integrity, Excellence, and Respect for People in everything that we do. 

Lilly is designing and building a new state of the art Parenteral, Device, and Packaging Assembly Facility in Raleigh-Durham North Carolina.  This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. 

The QA Data Steward serves as a power user and data steward for IT systems supported by Quality Assurance including LIMS (Darwin), MES(PMX), SAP, TrackWise, Veeva Quality Documents, and Certificate of Analysis management.  The QA Data Steward is responsible for improving business processes and supporting customer service interactions to ensure key business objectives are met.  The QA Data Steward represents Quality Assurance on projects, including lean initiatives.  Finally, the QA Data Steward is responsible for activities that include change controls, non-conformance investigations, procedure revisions, impact assessment reviews, creation and revision of specifications, review and approval of cGMP documents, and maintaining regulatory compliance.

Key Objectives/Deliverables:


  • Support the QA Compliance team and site in the development and execution of the site readiness plan with focus on supporting start up of new systems and oversight of the establishment of site data.

  • Power User for IT systems supported by QA including LIMS (Darwin), Manufacturing Execution System (PMX), SAP, Deviation/Change (TrackWise), Document Management (Veeva Q Docs).

  • Creates/revises site compliance area documents, including specifications and procedures.

  • Collaborates with cross-functional partners, such as Operations, MS&T, Engineering, Logistics and QC Labs, to streamline processes and sustain customer service.

  • Investigates non-conformances.

  • Approves GMP documents (examples: L1 non-conformances, procedures and L1 change controls).

Minimum Requirements:


  • At least 4 years working in the pharmaceutical or medical device industry in QA roles.

  • Previous GMP data stewardship experience. 

  • Proficiency with GMP computer systems including Lab systems, CAPA systems, and Document Control systems.

  • Demonstrated strong oral and written communication and interpersonal interaction skills

  • Demonstrated strong technical writing skills.

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

  • Previous regulatory inspection readiness and inspection execution experience.

  • Ability to work 8 hour days – Monday through Friday

  • Ability to work overtime as required

  • Ability to travel up to 10% to Indianapolis, IN for meetings and coordination with global regulatory organizations.

Additional Preferences:


  • Previous facility or area start up experience.

  • Experience as a power user or data steward for Darwin, PMX, Kneat, SAP, Veeva Q Docs.

  • Six Sigma Green Belt or Lean Training/Experience.

  • Knowledge of operations business processes, such as batch disposition, materials management, laboratory specifications and methods.

  • Previous equipment qualification and process validation experience.

  • Previous experience with SAP or other inventory management systems.

  • Previous experience with device and parenteral product materials.

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

  • Previous experience with deviation and change management systems including Trackwise

Education Requirements:

  • Bachelors degree in a science, engineering, computer, or pharmaceutical related field of study or equivalent industry experience.

Other Information:


  • The position is for the Lilly Research Triangle Park site and during the project phase will allow for a flexible working environment will the ability to periodically work remotely based on the project phase and site activities.

  • Position may require a short duration assignment of 1-2 months in Indianapolis to establish specific device knowledge and establish global contacts.

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.