(Senior) Associate – Quality Assurance Clinical Trials
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.
Come join us as as (Senior) Associate – Quality Assurance Clinical Trials
This position is a fixed term contract for 12 months based out of our Bad Homburg offices.
Your Responsibilities:
- Quality Oversight
Provide comprehensive quality oversight for clinical business areas by monitoring compliance with quality system documents. Anticipate potential gaps and proactively suggest solutions, escalating issues to management when necessary. Ensure regional and affiliate Quality Plans are implemented and track progress on corrective actions. - Quality Systems Management
Contribute to developing and maintaining quality system documents, tools, and resources. Ensure clear accountability for quality system requirements at regional and affiliate levels. Recommend updates or new documents as needed and advise on appropriate training for effective implementation. - Audit and Inspection Support
Lead and support audit and inspection readiness activities, including preparation, coordination, and managing responses. Ensure trial sites and teams are inspection-ready by organizing necessary documentation and facilitating pre-inspection visits. Oversee timely completion of audit corrective action plans. - Collaboration and Partnership
Serve as the primary quality consultant for business areas, partnering to strengthen quality controls and share best practices. Collaborate with other quality groups to build a quality network, participate actively in meetings, and support issue resolution using a risk-based approach. Support key projects as assigned. - Consultation and Risk Management
Provide expert consultation on interpreting and applying regulatory requirements and quality standards. Manage deviations, change controls, and notifications to management, ensuring proper documentation and escalation. Support root cause analysis and CAPA processes, and contribute to risk assessments, audit planning, and quality plans. - Process Improvement and Metrics
Drive simplification and continuous process improvement initiatives. Regularly review quality metrics and trends to identify weaknesses or gaps, recommending corrective actions to enhance compliance and operational efficiency. Monitor the completion of deviations, change controls, CAPAs, and audit responses to maintain quality standards.
Your Profile:
- Educational Background and Experience
Bachelor’s degree in science, technology, healthcare, or equivalent experience. Demonstrated experience applying quality systems within clinical trials management is essential, preferably with prior quality assurance roles. - Project and Time Management
Proven ability to manage multiple projects and tasks effectively, prioritizing work to meet deadlines. Strong organizational and self-management skills are required to handle concurrent responsibilities. - Communication and Influence
Excellent written and verbal communication skills, with the ability to influence stakeholders at various levels. Able to clearly convey quality expectations and foster collaboration across diverse teams. - Analytical and Cognitive Skills
Strong problem-solving, critical thinking, and analytical abilities. Attention to detail and verbal reasoning skills are important to assess quality data, identify risks, and drive improvements. - Interpersonal and Flexibility
Demonstrated interpersonal skills with the flexibility to work in varying cultural and geographic environments. Ability to work independently and collaboratively within global teams. - Additional Preference
Experience working in a global quality assurance environment is highly desirable. Knowledge of quality systems, regulatory requirements, and clinical trial processes will enhance effectiveness in the role.
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