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 responsibilityEnsure quality assessments are conducted to monitor the quality of clinical development within the business areaMonitor and report metrics to business managementEvaluate and support quality initiatives of business partnersRepresent Lilly both internally and externally in the area of clinical development, regulatory or safety qualityAudits and Inspections
Facilitate and / or deliver audits, regulatory inspections, and regulatory responsesEnsure ongoing inspection readiness of areaEscalate issues that will significantly impact clinical development activities, portfolio delivery, and business priorities, and recommend necessary follow-up actionsProject Management and Process Improvement
Identifies and may drive projects for the development and implementation of the SEQSSupports global process improvement initiativesShare learning and ensure communication to share best practice within business area and across the Medicines Quality OrganizationMinimum Qualification Requirements :
Bachelor s Degree, preferably in a health-related or scientific fieldExperience in clinical developmentSupervisory experienceExperience working in a global environmentStrong leadership and self-management skillsStrong verbal and written communication skillsKnowledge of GCP guidelines, GxPs, and regulations within the area of responsibilityDemonstrated problem solving and critical thinking skillsRole : 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
Skills Required
Gcp, Change Management, Process Improvement, Project Management