Hiring company: Lilly
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.
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 building a new state of the art Parenteral, Device, and Packaging Assembly Facility in Raleigh-Durham North Carolina. The Senior Quality Assurance Representative is responsible for demonstrating leadership, teamwork, and quality and regulatory knowledge and oversight to provide guidance, consultation and influence in the design, verification, and startup of the Device, Packaging, and Warehouse areas. This position is essential for ensuring GMP compliance in the design, delivery, start up to ensure regulatory approval of the facility by regulatory agencies.
Key Objectives/Deliverables:
- Act as a cGMP expert, working with Global Facility Delivery, Lilly project staff, and A&E firm to complete the detailed design of the assigned areas employing QbD and QRM principals and ensuring the integration of Global Quality System requirements into the design, verification, validation, and start up.
- Interact with the other global, project and functional areas to coordinate design and start up activities to support the overall project and site schedule.
- Consult with Network and Global quality groups as required to ensure consistent and compliant approach is executed during the project and startup phase.
- Actively participate in required design reviews and final design qualification activities.
- Provide technical and quality review and approval of project documents to ensure compliance with Lilly Global Quality Standards as well as project and local quality procedures.
- Work with the Site Quality Leader to support the development of the vision and strategy for the overall site quality operation with focus on the Device, Packaging, and Warehouse areas.
- Support the site organization in building technical capability, for a diverse cross-functional staff in Quality, the project team, and area process teams, including mentoring of new Quality and other project staff.
- Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group.
- Support the definition and execution of inspection readiness activities.
- Lead project initiatives needed in support of the project and Quality function.
- Resolve or escalate any compliance issues to the project, site, and Quality Management.
- Responsible for maintaining a safe work environment, working safely & accountable for supporting all HSE Corporate, Project, and Site Goals
Minimum Requirements:
- At least 10 years pharmaceutical experience.
- At least 4 years of quality knowledge and expertise in Device and / or Packaging manufacturing and quality.
- Previous experience with C&Q / Verification and Validation oversight including computer systems
Additional Preferences:
- Previous quality knowledge and oversight of warehouse operations.
- Previous experience with capital project delivery.
- Previous experience with Manufacturing Execution Systems including PMX, Palletti.
- Previous experience with SAP
- Previous experience with automated warehousing, incoming receipt and release processes.
- Previous use of KNEAT – or other electronic validation software.
- Previous computer system oversight.
- Strong technical aptitude and ability to train and mentor others.
- Demonstrated ability to communicate with cross-functional teams including good oral and written communication skills.
- Ability to work independently as a Quality SME with the project team with minimal supervision.
- Proficiency with computer systems including Microsoft office products, Trackwise, etc.
Education Requirements:
- Bachelors or equivalent degree in a scientific field
Other Information:
- External Candidates - Position would be for the 3 year delivery of the facility and transition to a site role. Position is RTP, NC based.
- Internal Candidates - Current position is for the approximate 3-year design and project delivery phase of the project only. The role could be completed either by relocation for the duration of the project or be completed with business travel throughout the project phase.
- Tasks may require repetitive motion (e.g., keyboarding).
- Ability to work 8 hour days – Monday through Friday required
- Ability to work overtime as required.
- Available off shift to respond to operational issues as needed is required
- Ability to travel up to 50% of the time or potentially relocate during the project phase to support the design and startup of the facility.
For internal employees, if you are currently in a technical path role, but outside of the posting band, you may apply. You will be hired at your current level. For example: Current P4 (tech ladder), Posting R1-2 tech ladder, hire will occur at P4
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.
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. If you would like to request an accommodation for medical or religious reasons, you may do so at workplace_adjustment@lilly.com.