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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Senior Manager Clinical Quality


Reference:SCA014763 Location: Cork
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Quality Manager, Quality Specialist, Quality Systems Lead

Senior Manager, Clinical Quality
Our client, a global pharma company, are currently recruiting for a Senior Manager Clinical Quality, to join their Global Medicines Quality Organisation (GMQO) on a permanent basis. The Senior Manager Clinical Quality, will play a critical leadership role in maintaining, developing, and enhancing quality system compliance. This position is instrumental in driving quality improvements and ensuring audit and inspection readiness across assigned portfolios or functions. Key responsibilities include managing resources, leading a high-performing team (people management experience is essential), overseeing quality-related projects, and supporting global submissions to health authorities. This role leverages technical expertise and a deep understanding of internal procedures and external regulatory expectations to guide a team of quality professionals. This role offers hybrid working.

Responsibilities

  • 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
  • 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
  • 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 the organisation both internally and externally in the area of clinical development, regulatory or safety quality
  • 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
  • Identify and drive projects for the development and implementation of the SEQS
  • Support global process improvement initiatives
  • Share learning and ensure communication to share best practice within business area and across the Medicines Quality Organisation

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
For more information please contact Sinéad Cullen on +353879500821 or [email protected]