Job Summary:
The Quality Systems AI Manager (QSAIM) is a subject-matter expert responsible for designing, implementing, and continuously improving the Quality Management Systems (QMS) and processes within PML’s over the counter (OTC) drug and cosmetic manufacturing environment. This role sits at the intersection of regulatory compliance, operational excellence, and emerging AI technology — embedding intelligent automation into investigation management (Deviations, OOS, Complaints), CAPA, change control, supplier quality, validation, and audit-readiness programs.
The ideal candidate is a quality professional with deep Quality Systems knowledge (FDA 21 CFR Parts 210/211, ICH Q10, USP standards) who is equally comfortable piloting machine-learning tools, evaluating AI-powered inspection platforms, and coaching cross-functional teams on data-driven quality culture.
This hands-on leadership role combines strategic and risk-based quality system management with AI technologies to improve efficiency while maintaining compliance and implementing continuous improvements to ensure product safety, efficacy, and regulatory compliance throughout equipment, systems and process lifecycles. This position requires a detail-oriented leader who can balance AI-based operational excellence with regulatory requirements in a fast-paced, client-focused manufacturing environment.

Essential Duties and Responsibilities:
AI-Enabled Quality Systems & Continuous Improvement

• Lead the evaluation, validation, and deployment of AI/ML tools for real-time process monitoring, anomaly detection, and predictive quality analytics.
• Partner with Technology team and data engineering teams to build automated dashboards that surface quality KPIs, such as but not limited to supplier quality, deviation/OOS/Compliant trends, and signals from data streams.
• Champion the use of Natural Language Processing (NLP) based tools for intelligent metric trending in various areas of quality systems, such as root-cause analysis and classification, risk-based supplier qualification assessments and CAPA effectiveness prediction.
• Design and execute AI models or templates for various quality-controlled documents, such as process validation protocols and reports, equipment qualification protocols and reports (IQ/OQ/PQ), investigation reports, supplier qualification assessments, aligned with GAMP 5 and FDA Computer Software Assurance (CSA) guidance as required.
• Identify and eliminate non-value-added quality activities through Lean/Six Sigma methodologies supported by data analytics.
• Facilitate cross-functional improvement teams; track benefit realization via documented continuous improvement (CI) project portfolios.
• Develop and report on key metrics related to areas of responsibility, including statistical analysis as needed.

Training, Culture & Cross-Functional Partnership

• Develop, review, write, and implement SOPs for new AI-Enabled Quality Systems and processes.
• Develop and deliver training curricula for new quality systems or processes, including modules on AI tool usage within a regulated environment.
• Serve as internal quality consultant to manufacturing, R&D, supply chain, and commercial teams.
• Mentor junior quality associates; foster a continuous-improvement mindset across the organization.
• Participate in management review and quality review meetings; prepare quality performance summaries as required.
• Partner with Quality, Manufacturing, Engineering, R&D, Supply Chain, Commercial teams and site leadership to resolve technical issues, support process improvements, and foster a culture of compliance.
• Maintain and demonstrate expertise in applicable regulatory requirements GMP, FDA regulations (21 CFR Parts 11/210/211), and ISO 22716 for cosmetics and OTC drug products.
• Willingness to travel to company facilities as needed, up to 50%.
• The scope of this role will evolve alongside the organization's AI strategy as new tools and technologies are explored and adopted.

Qualifications:

• Bachelor’s degree in STEM, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline.
• 5+ years of quality systems, quality assurance, or quality engineering experience in OTC drug manufacturing environment.
• Demonstrated working knowledge of quality systems and regulatory requirements (21 CFR Part 11/ 210 / 211), including data integrity practices.
• Hands-on experience managing and leading QMS and cross functional teams.
• Practical experience applying data analytics or AI/ML tools in a manufacturing or quality context (e.g., predictive analytics, NLP).
• Exceptional analytical and problem-solving abilities, excellent leadership, communication and technical writing skills.
• Strong organizational abilities, attention to detail, and the ability to manage multiple priorities in a fast-paced environment.
• Proficiency in Microsoft Office and familiarity with electronic quality systems.

Physical Requirements:

• Ability to lift and move objects weighing up to 25 pounds regularly and occasionally heavier items with assistance.
• Ability to stand, walk, bend, stoop, push, and pull for extended periods during shifts.
• Good understanding of safety protocols and practices.
• Willingness to work flexible hours, including shifts and weekends.

At Prime, we believe that a diverse, equitable and inclusive workplace makes us a more relevant, more competitive, and more resilient company. We welcome people from all backgrounds, ethnicities, cultures, and experiences. Prime is an equal opportunity employer.