Role and Responsibilities: - Drive and ensure quality compliance across all departments involved in New Product Introduction (NPI) processes.
-Lead and develop direct reports within the regulatory and manufacturing quality teams, specifically supporting NPI projects.
- Make certain that direct reports working on NPI initiatives receive necessary training and resources to execute their responsibilities effectively.
- Design and implement robust quality systems and procedures tailored to NPI requirements, fully aligned with FDA regulations and ISO standards.
- Champion quality representation throughout the lifecycle of new product launches and continuous improvements to existing products.
- Address customer complaints and queries related to NPI products, ensuring prompt and thorough resolution.
- Guarantee compliance with product development protocols and design controls during NPI activities.
- Collaborate across departments to facilitate the execution of regulatory strategies for new product introductions.
- Assess regulatory requirements for newly developed or modified products within the NPI scope.
- Ensure complete adherence to applicable regulatory requirements for all NPI projects.
- Track and audit quality-related activities specific to NPI operations onsite.
- Initiate and manage non-conformance reports and CAPAs for quality issues arising from NPI, ensuring comprehensive investigations and corrective actions.
Required Experience & Skills: - Bachelor's degree (level 7 or higher) in quality or a related discipline.
- Minimum of 3 years of proven people management experience.
- 5-10 years of experience in a regulated industry.
- Strong knowledge of Quality Management Systems (QMS), FDA regulations, and ISO standards & NPI.
- People Management Experience is essential.
Adecco Ireland is acting as an Employment Agency in relation to this vacancy.