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Lilly Site Compliance - QA Data Steward and Quality Systems in Research Triangle Park, North Carolina

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. 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.

Responsibilities:

  • 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).

  • Monitors and communicates Site Quality metrics

  • Facilitates Site Quality Metrics reviews within Site Quality Lead Team

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

Basic Requirements:

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

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

Additional Preferences:

  • 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.

  • Previous regulatory inspection readiness and inspection execution experience.

  • 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 Track wise

Additional Information:

  • 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.

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 ( LillyRecruitingCompliance@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.

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).

#WeAreLilly

At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people.​ We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!

#WeAreLilly

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