Role and Responsibilities:Scroll down for a complete overview of what this job will require Are you the right candidate for this opportunity
- 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 and 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.Additional Notes: Tasks and responsibilities will vary with all positions, and the scope of each role may not be limited to the contents listed on this job description.The employee's manager is responsible for communicating any changes deemed necessary to the quality department.It is the employee's responsibility to adhere to company procedures and GMP in the company as part of their job description.
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