A Brief Overview The Manager, Quality Assurance Documentation and Data is responsible for leading the site's document control and quality management system (QMS), ensuring compliance with regulatory requirements and internal standards. This role oversees QA documentation processes, including SOP management, change control, and quality records, while managing a team of QA documentation specialists. The Manager partners cross- functionally to support quality investigations, audits, and new product introductions, ensuring accurate, timely, and compliant documentation practices. This position also drives data integrity, reporting, and continuous improvement initiatives to enhance the effectiveness of the quality system. What you will do • Participate in quality investigations (root cause analysis action plan). Support new product introduction and other major changes and projects as the subject matter expert. • Ensure compliance with regulatory requirements (e.g., FDA, GMP, ISO). Develop, maintain, and revise standard operating procedures (SOPs) as needed. • Manage, train, and evaluate QA staff to ensure efficient operations and compliance with policies. Assign tasks, monitor performance, and provide feedback. • Conduct regular audits of department processes to verify compliance with customer requirements, regulations, and quality standards. Support regulatory inspections and audits as a subject matter expert. • Review and maintain accurate records of quality tools such as logbooks, change controls, annual product reviews, production manuals, employee signature logs, and more. Prepare and report KPIs and metrics to management as required to communicate the status of the quality system. • Initiate and support corrective and preventive actions (CAPA). Benchmark processes with other site locations and departments for best practices. • Provide technical support and training to team members on quality processes. • Maintain awareness of regulatory changes to ensure ongoing compliance. • Maintain timely tracking of processes. • Some duties may vary slightly by location. Education Qualifications • Bachelor's Degree in Chemistry, Engineering, or a related science (Preferred) or • equivalent job experience (Required) Experience Qualifications • 4-6 years in quality assurance, preferably in personal care, cosmetic, or drug product manufacturing or another highly regulated industry. (Required) • 1-3 years management experience (Preferred) • 1-3 years with electronic quality management systems such as QT-9 (Preferred) Skills and Abilities • Knowledge of FDA, GMP, and ISO standards. (High proficiency) • Proficiency in QA-related software and Microsoft Office Suite. (High proficiency) • Ability to create and review detailed reports, procedures, and audit documentation. (High proficiency) • Thoroughness in reviewing data and ensuring compliance with standards. (High proficiency) • Proficiency in inspection methods, sampling, and statistical process control (SPC). (Medium proficiency) • Ability to conduct root cause analysis and develop corrective/preventive actions (CAPA). (Medium proficiency) • Skills in team management, coaching, and conflict resolution. (Medium proficiency) • Ability to communicate effectively with cross-functional teams and external auditors. (Medium proficiency) • Proficiency in interpreting quality metrics and generating actionable insights. (Medium proficiency) • Familiarity with Six Sigma, Lean principles, and other improvement methodologies. (Low proficiency)