Global Medicines Quality Organization (GMQO) Sr. Manager Role
Lilly is a global healthcare leader committed to making life better for people around the world. We unite caring with discovery to improve health and well-being.
The purpose of this role is to maintain, develop, and improve quality system compliance and enhance quality by partnering with assigned portfolio/function(s). This position leads GMQO associates responsible for supporting the execution and delivery of submissions to global health authorities.
Primary Responsibilities:
* Leadership and Resource Management:
o Recruit, develop, and retain a diverse and highly capable workforce
o Ensure robust individual training plans and timely completion of required training for direct reports
o Enable talent identification and career development that reflects an end-to-end mindset and demonstrates judgement-based decision making
o Manage workload based on portfolio prioritization, regional requirements and individual level of expertise, and address implications to overall resource management and strategies
o Support and encourage a culture of innovation and model inclusivity to ensure diverse voices and ideas are heard and considered
* Quality System Implementation:
o 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
o Ensure quality assessments are conducted to monitor the quality of clinical development within the business area
o Monitor and report metrics to business management
* Audits and Inspections:
o Facilitate and/or deliver audits, regulatory inspections, and regulatory responses
o Ensure ongoing inspection readiness of area
* Project Management and Process Improvement:
o Identifies and may drive projects for the development and implementation of the SEQS
o Synthesize knowledge from various sources to identify solutions to complex problems
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
This role requires strong leadership and problem-solving skills, as well as the ability to work effectively in a global environment.