Quality Assurance Manager

GLP QA Manager – Somerset NJ

Key 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.