Sr. Manager

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

Role: Quality Manager / Supervisor

Industry Type: Pharmaceutical & Life Sciences

Department: Quality Assurance

Employment Type: Full Time, Permanent

Role Category: Business Process Quality

Education

UG: Any Graduate

PG: Any Postgraduate