Quality Assurance Manager

Somerset NJKey Responsibilities: Independently plan, execute, document, and follow up on complex study, facility, process, and system audits, as well as vendor qualifications. Prepare, review, and finalize Quality Assurance Statements and other quality documentation. Facilitate and support regulatory inspections and sponsor audits, including preparation, coordination, and follow-up activities. Take ownership of an assigned QA focus area, such as Vendor Qualifications, Process Audits, Continuous Improvement, or another area aligned with organizational priorities. Conduct quality risk assessments, evaluate potential impacts, and provide quality input to critical business and operational decisions. Lead or support investigations into deviations, non-compliances, and quality issues, including root-cause analysis and development of appropriate corrective and preventive actions. Assess compliance with GLP requirements, regulatory expectations, and internal procedures, identifying opportunities for improvement. Provide guidance and mentorship to QA Officers and junior QA staff, including participation in onboarding, training, and professional development. Represent QA in cross-functional and interdepartmental quality initiatives. Contribute to audit planning, scheduling, and prioritization based on risk and business needs. Support the development, maintenance, and continuous improvement of QMS.Maintain a high level of inspection readiness across relevant departments and processes. Proactively identify and resolve quality issues and develop practical, risk-based solutions. Develop and improve audit methodologies, tools, templates, and processes to enhance QA effectiveness and consistency.

Core Competencies: Quality & Regulatory Expertise: Applies strong knowledge of GLP and regulatory expectations to ensure sustained compliance. Analytical Thinking: Thoroughly evaluates information, identifies trends and root causes, and reaches well-supported conclusions. Communication: Communicates clearly and effectively across departments, functions, and organizational levels. Leadership & Mentoring: Provides guidance and support to junior QA staff and contributes positively to team development. Assertiveness & Collaboration: Confidently raises quality concerns while maintaining constructive and supportive relationships. Continuous Improvement: Identifies opportunities to strengthen quality systems, audit practices, and organizational processes. Ownership & Accountability: Takes ownership of assigned responsibilities and QA focus areas and follows through to completion.