Associate Vice President/Vice President Global Medicines Quality Organization

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.

The Associate VP / VP, Global Medicines Quality Organization (GMQO), is responsible for providing leadership to the design, maintenance and implementation of integrated global quality systems that support Research and Development (R&D) activities primarily in the areas of clinical development, patient safety, and regulatory affairs. The Associate VP / VP provides direction 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. To achieve this, the Associate VP / VP works 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.

Responsibilities:

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description.

Leadership/Supervision

• Ensure a sustainable and technically capable organization is in place.

• Enhance the capabilities of the organization through effective recruiting, training, coaching and development of GMQO personnel.

• 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.

• Partner with leadership across functions to ensure a shared vision for quality and to strategically position quality to enable critical business strategies.

Quality Execution, Monitoring, and Continuous Improvement

• Ensure the ongoing execution and monitoring of a global quality system that effectively supports Lilly-sponsored clinical development, patient safety, and regulatory activities conducted by Lilly and third parties.

• Provide quality support through consistent application of global processes to portfolio, functions, business units, and affiliates.

• Assure appropriate notification to management and resolution of quality related issues.

• Ensure consistent inspection readiness. Establish processes for the management of internal and external audits and ensure any findings are addressed in a timely manner.

• Provide quality leadership to the oversight and governance of third parties contributing to Lilly-sponsored clinical development, ensuring compliance, quality, and continuous improvement are achieved.

External Focus

• Monitor external regulatory and industry direction for incorporation into the design and execution of R&D processes.

• Actively engage with appropriate external organizations and agencies to influence the environment and anticipate changes.

Basic Qualifications/ 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.

• Ability to assess and manage risk in a highly regulated environment.

• Ability to evaluate business needs and develop strategic plans that assure quality and/or drive quality improvement.

• Experience working with external partners.

Additional Preferences:

• Additional experience beyond clinical development specifically in patient safety and regulatory

• Master of Science or PhD preferred

• Ability to collaborate with internal business partners and achieve results through them

• Strong leadership and employee management skills

• Strong teamwork and communication skills

Additional Information:

• Infrequent travel required.

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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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