Site Quality Assurance Head

As the Site Head of Quality Assurance, you will report to the VP of Quality and Regulatory Affairs and hold responsibility for the comprehensive cGMP quality management system at Nitto Avecia's Cincinnati site. The role entails direct oversight of critical quality functions, encompassing Quality Assurance, Quality Systems, and Validation.Key responsibilities:Foster a positive quality culture focused on compliance and continuous improvement, ensuring effective oversight of critical quality systems and operations to deliver high-quality products on time.Collaborate with cross-functional teams to always ensure regulatory inspection readiness.Manage inspections, internal audits, and external audits, act as the primary point of contact during regulatory inspections and interactions. Ensure compliance with pre- and post-approval regulatory commitments.Ensure effective management of quality systems: timely completion of GMP staff training, thorough deviation/OOS investigations leading to root cause identification and effective CAPA, implementation of timely and effective changes, on-time material/in-process control/product testing, and lot disposition.Develop and present in QMR quality metrics to monitor and analyze key parameters for quality compliance, operational quality, and continuous improvement.Implement and oversee data integrity controls in manufacturing, laboratory, and other GMP support functions.Implement a contamination control strategy.Guide and mentor the quality team to achieve their objectives; identify areas for improvement and development, providing necessary support to enhance skills and capabilities.Collaborate with site leadership, corporate, and senior stakeholders to establish quality goals, budgets, and strategies supporting sustainable growth.Job Knowledge Required:Advanced scientific degree preferred (Master of Science, PharmD, PhD) or Bachelor's degree with significant relevant experience.Minimum of 15 years of experience in the pharmaceutical or biotech industry, with experience in CDMO preferred.At least 10 years of quality assurance experience, including a minimum of 5 years in a management role within site quality functions.Preferred experience in hosting regulatory inspections and supporting product PPQ and commercialization.Deep understanding of international regulations such as FDA 21CFR, EU EudraLex Vol 4, USP, EP, JP.Expertise in ICH guidelines (Q2, Q7, Q9, Q10, Q11), good knowledge of ICH Q1, Q3, Q14, and regulatory guidance documents related to process and computerized system validation.Strong critical thinking and problem-solving skills.Excellent organizational, planning, and communication skills.Effective time management skills to support rapid business growth.Ability to lead, motivate, coach, and train team members and non-quality personnel effectively.

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