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Associate Director-MQO Research and Clinical Laboratories

2 months ago

Indianapolis, Indiana, United States Eli Lilly and Company Full time

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Organization Overview:

Associate Director- MQO Research and Clinical Laboratories

The Medical Quality Organization (MQO) is actively seeking an Associate Director. 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.

The Associate Director will play a crucial role in supporting clinical trials, liaising with third-party organizations, and maintaining familiarity with a broad spectrum of global and local regulatory agencies. They will leverage their extensive technical expertise to support various laboratory information systems, acting as the primary representative for Business Quality Assurance.

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.

Beyond these responsibilities, the Associate Director will orchestrate learning and employee development initiatives, disseminate technical best practices, and equip the team to navigate new regulatory and operational challenges with a quality-first approach.

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.Manages career development activities, talent identification, performance evaluation, and evaluation of continuous improvement opportunities.Manage team member workload.Drives culture of innovation, inclusivity, ensures diverse ideas and points of view are heard and considered.Lead by example, coaches and mentors staff for work procedures, issue identification/ resolution (SEQS, DRQS, and CDL).Identifies/drives projects and process improvement initiatives.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 necessaryConsults 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 5 years of experience in a Clinical Laboratory, Pharmaceutical Research and/or Quality.Laboratory Information System Management experience
Additional Skills/Preferences:Direct experience within Quality and/or demonstrated understanding and application of quality management systemsAdvanced degree in a scientific field, statistics, or data science.Supervisory experienceExperience working in a global environmentProven mastery of data integrity principles in drug development and clinical researchDemonstrated 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 skillsStrong verbal and written communication skillsKnowledge of CLIA, GCP guidelines, GxPs, and regulations within the area of responsibilityDemonstrated problem solving and critical thinking skills 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 ( ) 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. #WeAreLilly