Associate Director, Quality Assurance - Change Control - Hybrid

• IRL - Dublin - Leopardstown (Red Oak)
• IRL - Dublin - Blackrock
• IRL - Tipperary - Ballydine
• IRL - Dublin - Swords (Biotech)
• IRL - Meath - Dunboyne
• IRL - Cork - Brinny
• IRL - Carlow - Carlow

Are you a leader who thrives in a dynamic environment and is passionate about making meaningful contributions? If so, consider joining us as an Associate Director, Quality Assurance Change Control. In this role, you'll be key to refining a more efficient and effective change control process. You'll engage with stakeholders worldwide and become a vital part of our Manufacturing Division journey. 

Your Core Responsibilities 

• You'll have the responsibility of keeping abreast with health authority regulations and incorporating them into the Quality Management System change control documents. 
• You will author and maintain global change control documents, ensuring their alignment with other Quality Management System topics. 
• This role will enable you to support the development and enhancement of Change Management processes and systems. 
• Partner with various teams to intertwine processes with change control and provide your subject matter expertise. 
• You'll develop and deliver compelling global training materials for our Manufacturing Division personnel. 
• Lead the Change Control community of practice and manage its website content, becoming a recognizable figure within our company. 
• You'll troubleshoot network change control issues and guide their resolution, being the go-to person for problem-solving. 
• Interface with our IT group for system improvements and travel (~20%) to support the change control process at our Manufacturing Division global sites. 

Who You Are 

You are ready if you have: 

• We're looking for someone with a Bachelor's degree in Science or Engineering. 
• A minimum of 5 years' experience in a GMP environment is a must. 
• Proficiency with Change Control and related IT systems ideally in Veeva  
• We value a mindset geared towards continuous improvement and action. 
• Familiarity with international GMP policy and regulations. 
• Ability to travel 20/25% throughout Europe with some US travel required. 

Nice to have, but not essential: 

• We'd love someone with demonstrated personnel management/leadership skills. 
• Demonstrated project management/leadership skills would be a bonus.