Senior Manager Clinical Quality

Life Science Recruitment; Cork; Hybrid; EUR 70,000 - 90,000; Full time

Job summary

A global pharmaceutical company is seeking a Senior Manager for Clinical Quality to join their Global Medicines Quality Organisation. This role encompasses leading quality improvements, overseeing teams, and ensuring compliance with regulations. Candidates should have a relevant degree and experience in clinical development.

Qualifications

• Experience in clinical development required.
• Supervisory experience is essential.
• Experience working in a global environment is preferred.

Responsibilities

• Manage and develop a high-performing team.
• Ensure compliance with quality systems and regulations.
• Lead quality reviews and audits.

Skills

Leadership

Communication

Problem Solving

Critical Thinking

Education

Bachelor’s Degree in a health-related or scientific field

Job description

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

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 [phone] or [e-mail]