Manage all validation activities for new, altered, or modified equipment, facilities, or manufacturing processes; Manage all GMP software validation activities for new, altered, or modified information technology platforms;; Responsible for the development, design, administration, and management of training initiatives and systems. Effectively own and manage all technical training and competency assurance programs for new-hires and existing staff;Management of the metrology department, stability department, and laboratory facilities team; Responsible for ensuring compliance with Data Integrity; Responsible for approval of highly technical investigations involving product impact, setting direction and policies for cGMP compliance activities; Budgeting and adherence for areas of functional responsibility; Directly interact with key customers relating to technical issues, potential non-compliance activities, or service issues impacted by quality/compliance; Resolution of critical quality issues that could impact production, customer service, quality, or compliance.

Responsible for developing, managing, conducting and supervising training and development programs for site employees. Manage direct reports for Training and Document Control, and responsible for the creation of a synergistic team that was historically separated. Partner with subject matter experts and various functional areas to identify and gain an understanding for key competencies for critical job areas. Manage the use of the electronic Learning Management and Document Management Systems. Identify gaps in learning and development programs, assess skills and competencies and drive continuous improvement to close gaps. Responsible for day to day oversight of document control processing and retention, labeling issuance, and continuous improvement projects driving compliance and cost savings.

Responsible for day to day oversight of document control processing and labeling issuance. Managing direct reports responsible for creation, processing, issuance, and retention of controlled documents, including finished API labels.Coordinate DMS Training and conduct instructor led training, and present Quality GMP overview during New Employee Orientation.Manage a cross-functional team for the review and approval of Safety Data Sheets.

Project Lead for Quality Processes and Continuous Improvements.Maintain quality document retention policies for regulatory compliance.Perform functional review of change controls from a Quality Document Control and Labeling aspect.Lead Trainer for Document Control and expert on Quality Systems for Documentation.Serve as back-up for Quality Document Control Manager.Investigate quality issues within the department and identify and implement corrective and preventative actions. Present Quality Orientation and instructor-led training for new hires and existing employees. Lead Annual GMP training. Lead and participate in internal and external audits.Assist in gathering production documentation (batch records, master processes, specifications, Certificate of Analyses, etc.) for DMF Reviews.

Manage documents (procedures, manufacturing batch records, master processes, quality specifications, etc) throughout their lifecycle in accordance with Company and regulatory guidelines. Oversee digital record retention, retrieval, and access of site-wide process specific records. Perform records management functions and improve existing operations for documentation systems. Lead Trainer for Document Control and expert on Quality Systems for Documentation and Present Quality Presentation for new hire orientation. Investigate unexpected events or quality issues within the department and identify corrective and preventative actions. Participate in internal and external audits.Serve as a cross-functional team member to resolve compliance and conformance issues. Maintain cross-training in the creation and releasing of finished product labeling.

Implement new procedures in the Document Management System. Assist in the update of controlled documents for the St. Louis Plant. Lead the document archival process following the document retention schedule.