Product Process Validation Manager

Job description

Our Work Matters At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make The is an exciting opportunity as Product Process Validation Manager is a key member of the Manufacturing Science & Technology (MS&T) organization, responsible for leading process validation strategy and execution across the product lifecycle. This role oversees the design, authorship, and facilitation of technology transfer activities, Process Performance Qualification (PPQ) protocols and reports, and supporting ongoing Continued Process Verification (CPV). The manager partners closely with Process Development, Quality, Manufacturing, and Regulatory Affairs to ensure robust, compliant, and efficient validation programs. This position reports directly to the Director of MS&T. Role Responsibilities Process Validation & PPQ: - Lead the development, authorship, and execution of process validation strategies in alignment with regulatory expectations (e.g., FDA, EMA, ICH Q8–Q11). - Write, review, and approve PPQ protocols, sampling plans, risk assessments, and final reports. - Facilitate cross-functional PPQ readiness, including coor...