Associate Director, Global Quality Systems

4 weeks ago


Marquand, Missouri, United States Eli Lilly Full time
Job Summary

We are seeking a highly experienced and skilled professional to lead our Global Quality Systems team. As Associate Director, Global Quality Systems, you will be responsible for providing strategic leadership and direction to the design, maintenance, and implementation of integrated global quality systems that support Research and Development (R&D) activities.

Key Responsibilities:

  • Provide leadership to the execution of quality systems, management of audit and inspection activities, and appropriate monitoring of the external environment to maintain sustainable compliance and drive continuous improvement.
  • Work with functional business areas and drug/device development teams across R&D, and with supporting areas including Ethics and Compliance, Legal, and other components of the Global Quality organization.
  • Ensure that the optimal organizational structure is in place for achieving objectives effectively and efficiently.
  • Enable desired behaviors throughout the organization through clear communication and respect for people.
  • Simplify and prioritize work to enable effective decision making.

Requirements:

  • Bachelor's Degree in a science-related field
  • A minimum of 10 years of direct experience with clinical development, patient safety, or regulatory affairs with demonstrated understanding and application of quality management systems
  • Broad functional expertise and experience in clinical development and quality roles
  • Knowledge of industry practices and applicable clinical development quality standards and regulations
  • Experience working with regulatory authorities and in managing regulatory inspections

Preferred Qualifications:

  • Master of Science or PhD
  • Additional experience beyond clinical development specifically in patient safety and regulatory
  • Ability to collaborate with internal business partners and achieve results through them
  • Strong leadership and employee management skills
  • Strong teamwork and communication skills

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.



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