Job Title:
Sr. Manager, Global Medicines Quality Organization (GMQO)
Location:
Bangalore, Karnataka, India
Company:
Lilly
Job Description:
The Sr. Manager, Global Medicines Quality Organization (GMQO) is responsible for maintaining, developing, and improving quality system compliance while partnering with assigned portfolios and functions. This leadership role includes resource management, audit and inspection readiness, quality project management, and process improvement. The position leads GMQO associates who support submissions to global health authorities, leveraging technical expertise and knowledge of internal and external regulations to ensure quality execution and delivery.
Key Responsibilities:
Leadership and Resource Management:
Recruit, develop, and retain a diverse and capable workforce.
Ensure training plans and completion for direct reports.
Encourage talent development with an end-to-end mindset.
Manage workload based on portfolio priorities and resource strategies.
Model inclusivity, innovation, and strong coaching.
Quality System Implementation:
Facilitate quality reviews, deviation management, CAPA implementation, and quality assessments.
Monitor metrics to track clinical development quality and report to business management.
Represent Lilly in internal and external quality discussions within clinical development and regulatory areas.
Audits and Inspections:
Lead audits, regulatory inspections, and responses.
Maintain ongoing inspection readiness.
Escalate critical issues impacting clinical development and provide action recommendations.
Project Management and Process Improvement:
Drive projects for the implementation of the Safety and Efficacy Quality System (SEQS).
Support global process improvement initiatives.
Share best practices and learning across the organization.
Required Qualifications:
Education:
Bachelor’s Degree in a health-related or scientific field.
Experience:
Experience in clinical development and supervisory roles.
Experience working in a global environment.
Skills:
Strong leadership, communication, and self-management abilities.
Knowledge of GCP guidelines, GxPs, and relevant regulations.
Strong problem-solving and critical thinking skills.
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