Associate Director - MQO Safety

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.

Purpose:

The purpose of the Associate Director, Medicines Quality Organization (MQO) – Safety role is responsible for leading quality system compliance and quality improvement of the functions he/she supports. The Associate Director is responsible for managing the quality team supporting safety functions in performance management including development, team strategy implementation/execution, and process improvements. This role is also responsible for audit and inspection support and quality project management.

Primary 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. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

1. Leadership and Supervision

• Ensure team members understand the objectives of the organization and their role in supporting the company and MQO priorities.

• Ensure optimal resourcing and workload management to assure appropriate distribution of capacity and capabilities across the team.

• Lead performance management for personnel including holding individuals accountable for their goals, providing feedback and coaching, supporting development plans, and assuring appropriate training and qualification.

• Participate in succession planning as appropriate.

2. Quality System Implementation

• Ensure appropriate application of quality system management principles including deviation and change management, implementation and support of quality plans, self-inspections, quality system document management and quality issue resolution and escalations.

• Lead implementation and continuous improvement of quality standards.

• Provide consultation on the interpretation and practical application of quality related topics.

• Analyze and report quality system metrics and trending data.

3. Audits and Inspections

• Assure implementation of effective processes for the coordination and management of audits/inspections

• Lead audit/inspection activities.

• Ensure learning resulting from audits/inspections are communicated.

• Partner with business area representatives in the development of appropriate responses to findings and subsequent action plans as needed.

4. Project Management and Process Improvement

• Collaborate with business areas including but not limited to process owners and IT business systems support in the development/improvement and/or implementation of business processes and quality initiatives.

• Ensure implementation of methods for continuous improvement to strengthen quality control and quality assurance.

• Ensure best practices and shared learnings are disseminated within the business areas and across the MQO.

• Establish strong relationships with leadership of areas supported including external partners (e.g. third-party vendors, business partnerships)

• Understand the roles and responsibilities of the EU QPPV and ensure support of their legal responsibilities.

Minimum Qualification Requirements:

▪ Bachelor’s Degree, preferably in a health-related or scientific field

▪ Three to five years’ experience in quality and/or patient safety

Other Information/Additional Preferences:

▪ Health care professional

▪ Supervisory experience

▪ Strong leadership and self-management skills including ability to manage initiatives simultaneously.

▪ Ability to communicate effectively, both written and verbal

▪ Application of risk-based decision making in a regulated environment

▪ Ability to influence, challenge and work in cross-functional teams and at different levels.

▪ Excellent interpersonal, organizational and negotiation skills

▪ Strong knowledge of quality systems and/or experience in a quality control/quality assurance role

▪ Knowledge of pharmacovigilance regulations/guidelines

▪ Project management experience/skills

▪ Demonstrated ability to work in a global environment.

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