Sr. Principal Associate - MQO Research and Clinical Laboratories - Eli Lilly and Company

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.

Organization Overview:

The Medical Quality Organization (MQO) is actively seeking an Research and Clinical Laboratory Quality Representative. This individual will be tasked with upholding data integrity and compliance across a diverse array of laboratory environments, including discovery research, clinical laboratories, and clinical trials. The role involves ensuring adherence to quality systems, driving improvements, and fostering cross-functional collaboration with a variety of business partners.

Furthermore, the Associate Director will spearhead a team dedicated to supporting the portfolio, research, and clinical diagnostic laboratory deliverables. This will involve harnessing Data-Driven Quality initiatives, cultivating deeper quality and technical expertise, and integrating quality into innovation.

In this role, the Associate Director will also manage resources for team projects and portfolio support, all while maintaining the agility to adapt to the ever-evolving regulatory landscape. This position offers a unique opportunity to lead, learn, and make a significant impact in the field of medical quality assurance.

Responsibilities:

• Understands Quality Systems (SEQS and DRQS):  Procedures, Tools, Resources and how these are applied to business processes.
• Understands quality principles.
• Monitors and manages compliance, compliance issues, and understand appropriate escalation as necessary.
• Manages and implement business work via the Quality Management System:  Notification to Management, Deviations, Root Cause Analysis, Change Control, etc.
• Solves problems related to quality issues using good judgement-based decision-making principles.
• Manages business focused expectations.
• Establishes experiences working within a global capacity.
• Ensures compliance with Quality Systems, internal guidelines, and external regulations.
• Consults with business partners for strategic and practical application of policies and procedures.
• Demonstrates ability to negotiation, influence, and problem-solving behaviors.
• Demonstrates inclusive, team-focused behavior.
• Demonstrates good verbal and written communication in English.
• Demonstrates good project management, prioritization, and evaluation of critical from non-critical issues.
• Demonstrates ability to identify root causes, manage difficult business/quality.
• Enables execution of local, regional, and global regulatory requirements for laboratory and diagnostic.
• Influences direction of quality decisions, partners with cross-functional teams and provides technical and regulatory considerations.
• Implement the Quality Plans as appropriate for the relevant systems.
• Consults and facilitates audits and management of associated audit observations for the business and related TPOs.
• Evaluates business metrics for trends, identifies gaps, areas of weakness.
• Drives simplification, shares key learnings, seeks process improvements, and replicates best practices; Partners with business process owners; Utilizes risk-based approaches.
• Review, edits, manages and approves business documents.
• Handles sensitive information with confidentiality.
• Provides periodic Quality updates with business leadership.
• Supports projects as needed.
• Consults with other functional representatives, as necessary.
• Manages the recruitment, development, retention of a highly capable and diverse team.
• Ensures assignment of relevant training, completion of work expectations, MQO competencies and assignment of coaches as needed.
• Understands core functional business process.
• Understands in depth Laboratory systems, Laboratory Data requirements, Data integrity.
• Understand working with Third Party Organizations related to services including but to limited to: Clinical Laboratory and Diagnostics, such as imaging, ECGs and connected device requirements.
• Manages global regulatory inspection activities, including continuous inspection readiness and management of regulatory responses/ Corrective Actions/ Preventative actions.
• Utilizes and manage quality metrics for process improvement initiatives.
• Exhibits expertise in LIS management, validation, archiving, audit train expectations, and regulatory requirements.
• Demonstrates experience in CLIA, GLP, or other Research related laboratories.
• Understands Clinical and non-clinical Drug Development and GxP regulations, guidelines, and standards.
• Understands Third-Party Management, TPO On-boarding, Oversight and Quality expectations.
• Consults Information Technology and associate IT Quality representatives as necessary
• Consults and supports implementation of new process, advises on training requirements and quality content for business processes.
• Consults in assessment of risk, audit planning and quality plans.
• Ensures appropriate controls are implemented and documented for business or regulatory requirements.

Basic Requirements:

• Bachelor’s degree in Clinical Laboratory Sciences/ Medical Technology, life sciences, medically related field or equivalent work experience. 
• Minimum 3 years of experience in a Clinical Laboratory, Pharmaceutical Research and/or Quality.
   

Additional Skills/Preferences:

• Direct experience within Quality and/or demonstrated understanding and application of quality management systems
• Advanced degree in a scientific field, statistics, or data science.
• Supervisory experience
• Experience working in a global environment
• Proven mastery of data integrity principles in drug development and clinical research
• Demonstrated competency in engaging cross-functional team members to resolve issues while balancing timelines, various perspectives, and speaking up/leading when the destination is unclear.
• Strong leadership and self-management skills
• Strong verbal and written communication skills
• Knowledge of CLIA, GCP guidelines, GxPs, and regulations within the area of responsibility
• Demonstrated problem solving and critical thinking skills

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 (https://careers.lilly.com/us/en/workplace-accommodation) 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 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.

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