Sr. Manager, Global Medicines Quality Organization (GMQO)

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 purpose of the Sr. Manager, Global Medicines Quality Organization (GMQO) role is to maintain, develop, and improve quality system compliance and enhance quality by partnering with assigned portfolio/function(s).  This position is responsible for resource management, leadership, audit and inspection readiness, and quality project management and process improvement.

This position leads GMQO associates responsible for supporting the execution and delivery of submissions to global health authorities. To achieve this goal, the role uses their technical expertise and a strong working knowledge of internal procedures and external regulations/expectations.

Primary Responsibilities:

Leadership and Resource Management

• Recruit, develop, and retain a diverse and highly capable workforce
• Ensure robust individual training plans and timely completion of required training for direct reports.
• Enable talent identification and career development that reflects an end-to-end mindset and demonstrates judgement-based decision making
• Ensure MQO associate competencies are present and continuously improving
• Manage workload based on portfolio prioritization, regional requirements and individual level of expertise, and address implications to overall resource management and strategies
• Support and encourage a culture of innovation and model inclusivity to ensure diverse voices and ideas are heard and considered
• Coach others in the areas of work procedures, the Safety and Efficacy Quality System (SEQS), and issue resolution
• Lead by example through credible technical coaching
  

Quality System Implementation

• Support, define and/or facilitate quality reviews, quality consultations, deviation and change management, quality planning, CAPA implementation, quality assessments, quality issue resolution within area of responsibility
• Ensure quality assessments are conducted to monitor the quality of clinical development within the business area
• Monitor and report metrics to business management
• Evaluate and support quality initiatives of business partners
• Represent Lilly both internally and externally in the area of clinical development, regulatory or safety quality

Audits and Inspections

• Facilitate and/or deliver audits, regulatory inspections, and regulatory responses
• Ensure ongoing inspection readiness of area
• Escalate issues that will significantly impact clinical development activities, portfolio delivery, and business priorities, and recommend necessary follow-up actions

Project Management and Process Improvement

• Identifies and may drive projects for the development and implementation of the SEQS
• Supports global process improvement initiatives
• Share learning and ensure communication to share best practice within business area and across the Medicines Quality Organization

Minimum Qualification Requirements:

• Bachelor’s Degree, preferably in a health-related or scientific field
• Experience in clinical development
• Supervisory experience
• Experience working in a global environment
• Strong leadership and self-management skills
• Strong verbal and written communication skills
• Knowledge of GCP guidelines, GxPs, and regulations within the area of responsibility
• Demonstrated problem solving and critical thinking skills

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly 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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Experience Level

Senior Level