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Sr. Manager

Sr. Manager

ConfidentialBengaluru / Bangalore
30+ days ago
Job description

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

    Skills Required

    Gcp, Change Management, Process Improvement, Project Management

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