Associate Director / Director - 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.

Purpose:

The purpose of the Associate Director / Director, Global Medicines Quality Organization (GMQO) (M2/M2-2) role is to maintain, develop, and improve quality system compliance and enhance quality by partnering with assigned portfolio/function(s). This position provides strategic input, focuses on results, thinks critically, and emphasizes team collaboration to the achievement of goals and objectives.

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 GCP regulations/expectations. This position is responsible for leadership and resource management, quality system implementation, audit and inspection readiness, quality project management and process improvement.

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 supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

Primary Responsibilities:

Leadership and Resource Management

• Accountable for the recruitment, development, and retention of a diverse and highly capable workforce
• Responsible for ensuring individual training plans and timely completion of required training for direct reports.
• Responsible for talent identification and career development that reflects an end-to-end mindset and demonstrates judgement-based decision making
• Ensure GMQO 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
• Drives a culture of innovation and model inclusivity to ensure diverse voices and ideas are heard and considered
• Responsible for coaching and mentoring staff 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 effectively partner with the business on quality initiatives
• 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

• Identify and/or drive projects for the development and implementation of the SEQS
• Support and/or lead global process improvement initiatives
• Share learning and ensure communication to share best practice within business area and across the Global Medicines Quality Organization

Minimum Qualification Requirements:

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

Other Information/Additional Preferences:

• Demonstrated project management experience.

This is an Indianapolis-based position with at least 3 days per week on-site at Lilly Corporate Center.

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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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