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Associate-Clinical Quality

Associate-Clinical Quality
United States
North America
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.
Functional and Technical Expertise
  • Supports the Safety and Efficacy Quality System (SEQS) implementation and education of the business. Participates in SEQS procedure development and in Change Control as appropriate
  • Functions as the initial point of consultation for the business on SEQS related question
  • Responsible for providing input and feedback on quality standards and expectations
  • Consultants on regulations and guidelines; provides interpretation, direct input into quality systems and defines the quality direction to comply with external and internal expectations. Informs and interprets changes in local, regional and global regulations
  • Provides guidance and consultation to the business to enable execution of external and internal regulations on a local, regional and global level to , ensure compliance and inspection readiness
  • Provides input into Global Quality Auditing and Compliance (GQAAC) audit plans and regional and/or affiliate quality plans based on identified signal/risks/gaps
  • Defines, executes and documents quality self-assessments/self-inspections throughout the clinical development process and discusses output with business partners
  • Discusses output of quality self-assessments with business partners, provide recommendations on corrections and CAPA and monitor through to resolution
  • Supports and educates the business in developing robust CAPA, deviation management, root cause investigation, audit response management and inspection response management
  • Reports issues through Notification to Management (NTM) as appropriate
  • Participates in the development and implementation of the quality strategy for the Portfolio and Medical Affairs
  • Conducts process reviews based on quality data and trends. Shares results with the business

Inspection Readiness and Inspection Management
  • Leads pre-inspection preparation activities in collaboration with business partners
  • Prepares and educates internal and external customers/business partners (including investigator site staff) on inspection management
  • Actively supports site and sponsor inspections
  • Responsible for inspection response management and tracking through resolution
  • Coordinates audit responses including Trackwise system documentation
  • Functions as an expert in corrective and preventative actions (CAPA) management
  • Actively participates in lessons learned/shared learning sessions regarding clinical trial site support during inspections

Quality Decision Making
  • Uses risk based approach for effective communication to influence business decisions
  • Provides feedback to the business on the benefits and risks associated with an issue and/or business solution

Influence Quality Direction
  • Collaborates with other quality groups as appropriate and develops a quality network
  • Collaborates with compliance as appropriate and develops a working partnership
  • Shares key learning to drive simplification and replicate best practices
  • Actively participates in team and supported business area meetings
  • Acts as a point of contact and partner with compliance officer/Data privacy steward as appropriate
  • Consults on deviation management and root cause analysis
  • Utilizes quality experience to support change management and business transformation in the delivery of the portfolio

Problem Solving
  • Support business in resolution of issues
  • Supports business in the escalation of issues including the escalation to leadership
  • Anticipates broader impact of an issue

Quality Technical Leadership
  • Initiates, drives and coordinates quality improvement initiatives. Shares key learning's and drives quality into the business

Project Management
  • Supports the implementation of harmonization of best practices, process improvements and provides feedback on effectiveness of implementation, challenges and best practice
  • Supports local, regional and global medical teams working on key projects
  • Bachelor’s Degree in a science, technology or medically-related field
  • A minimum of 2 years experience in quality and/or related field
  • Knowledge of GxP regulations, guidelines and standards
  • Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
  • Global perspective and working across functional and geographical boundaries
  • Demonstrated understanding of quality principles, including policies, procedures and processes
  • Demonstrated ability to identify and prioritize quality issues.
  • Knowledge of the relevant regulatory framework
  • Ability to influence, negotiate and project manage
  • Ability to work effectively at all level of the organization
  • Effective organization/self-management skills
  • Excellent problem solving skills and initiative
  • Proficient written and spoken English language skills
  • Effective verbal communication
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.