Principal Scientist QC Compliance

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 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.

Description of Role/Position

The Senior/Principal Scientist QC role will have primary responsibilities for Sample Management and will lead and oversee sample and material management processes supporting the QC laboratories.

As the Sample Management process owner and primary audit SME, this role is critical in ensuring the integrity, traceability, and compliance of samples throughout their lifecycle.

The Principal Scientist will collaborate cross functionally to optimize sample workflows, develop and implement robust processes, and support continuous improvement initiatives including implementation of automated and digitalized solutions. The role requires strong leadership, technical expertise, and a deep understanding of GMP and regulatory requirements. As a member of the QC Support team they may also have responsibility to support equipment, quality and compliance, and training activities for QCL.

Key Responsibilities

• Lead coordination, receipt, inspection, and inventory of samples and reference materials.
• Ensure accurate documentation of sample movement and storage using LIMS and other systems.
• Maintain sample integrity and compliance with chain of custody protocols.
• Develop and implement efficient sample management processes across QC and manufacturing.
• Identify and drive continuous improvement initiatives to enhance sample handling and logistics through automation and digitalization of process and systems.
• Ensure all sample related activities comply with GMP and internal quality standards.
• Lead sample management related preparation and responses during audits and inspections by maintaining accurate and complete documentation and developing in depth understanding of sample management processes and procedures.
• Partner with Manufacturing, QA, QC, and external labs to resolve sample related issues.
• Coordinate sample shipments to third party laboratories, including temperature monitoring.
• Oversee inventory of samples, reagents, and reference standards, ensuring alignment between physical and electronic records.
• Support reagent inventory and lab support activities as needed.
• Provide technical guidance and mentorship to sample management associates.
• Support QC Support team members with equipment, compliance and training tasks.

Educational Qualifications/ Experience Required

• Bachelor's or master's degree in a Life Science or related field.
• Minimum of 7 years of experience in a GMP regulated QC or manufacturing environment, with a focus on sample management or laboratory operations.
• Proven experience in leading cross functional projects and process improvements.

Additional skills/preferences

• Expertise in sample chain of custody, LIMS systems (e.g., LabVantage), and temperature controlled logistics.
• Strong understanding of GMP documentation and compliance requirements.
• Experience with digital tools such as Binocs, One QMS and Veeva.
• Excellent organizational, communication, and stakeholder engagement skills. Ability to mentor and guide junior staff.
• Proactive approach to problem solving and continuous improvement.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly 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.