• Provide leadership, direction and mentorship across all levels of the organization. • Create and implement Quality Management System (QMS) from Clinical Phase 1 through Commercial stage compliance, including continuous improvement. • Work collaboratively across internal functions including Manufacturing, Analytical/Process Development, Quality Control, Reg Affairs and Supply Chain to ensure deliverables are met. • Manage product release activities (GMP & Research) including provisions of CofA and regulatory filing content. • Provide technical expertise on deviations, OOS/OOT, CAPA investigations and validations.• Create and implement internal training program for GMP, GDP, compliance, audit readiness, etc. • Manage day-to-day operations of QA team; including hiring, training, time management, and direction of staff. • Participate and lead audits as needed (internal, regulatory and/or partner).

• Ensure regulatory compliance with FDA and EPA GLPs and other regulatory agencies world-wide. • Maintain Master Schedule and Protocols of GLP studies and conduct study and facility audits. • Review and approve deviations, corrective actions, SOPs, and study data and reports. • Report to management and study director’s status updates on each study, including any nonconformities. • Lead cross-functional teams related to SOPs, improvements, and audits. • Perform inspections of subcontract laboratories and critical vendors to ensure compliance. • Create and perform training program for all NLS staff.

• Provide quality leadership to all functions throughout company, especially related to documentation, training, and systems implementation. Liaison to quality assurance group internally. • GMP Documentation Subject Matter Expert (SME) ensuring procedures are compliant to federal regulations.• Implementation of new employee training and compliance training (GMP, GDP, GCP, etc.).• Transfer of paper files to new electronic systems (MasterControl and ComplianceWire).• Ownership of archive, reorganization and implementation of electronic tracking system. • GAP analysis, process mapping, and creation of new procedures including policy and procedure templates.

•GMP Subject Matter Expert (SME) analysis, editing, and review of current Standard Operating Procedures (SOPs) and new inventory management system content.•Assist Program and Project Managers in ensuring deliverables are met and manage team progress.•Identify and track issues with documentation deliverables and report to management.•Develop strong relationships with other internal support groups including QA, QAD and compliance to ensure successful completion of project.

• Creating, editing and implementing new Standard Operating Procedures (SOPs) and manufacturing documents such as Master Batch Records, Quality Control Sheets, and Material Specifications. • Serve as a liaison with Manufacturing, Clients, Process Development, Quality, and other departments.• Identify LEAN enhancement options within processes and documents to improve practices and procedures. • Conduct training and provide assistance to internal customers on new and revised SOPs. • Facilitate initiation, progression and closures of Change Control issues, including the tracking and trending in database.

• Responsible for daily supervision and administration of Quality Management System (QMS) for GMP, Biologics and CAP (College of American Pathologists) CLIA (Clinical Lab Improvement Amendments) labs to ensure compliance with regulatory requirements, corporate policies and internal procedures. • Writing, reviewing & approving deviations, root cause analysis, change controls and corrective/preventive action (CAPA) plans, providing risk analysis, and ensuring completion of all follow-up. • Conduct internal compliance audits and assist in hosting audits conducted by clients and regulatory agencies for studies, reports, data, and processing systems as quality SME. • Author, review, and revise documentation such as Standard Operating Procedures (SOPs), study documentation and results, processes and data according to QMS. • Critical review, organization and quality oversight, of records and reports generated during development, validation, daily lab operations, sample testing, material control, equipment calibration and maintenance. • Coordinate across functional areas in formulating and establishing policies, procedures and goals.

•Manage archival, document issuance, creation & generation processes.•Maintain a working knowledge of governmental and global regulations. •Create new and improve existing procedures and systems to support document control•Serve as SME and trainer for all departmental tasks, duties and procedures for document control•Provide site training for Aegis and/or AZ docs and GMP/GDP regulations•Generate metrics for Quality Council and for tracking internal performance •Demonstrate the ability to understand and implement priorities and work load and establish strong collaborative relationships with peers •Support and participate in US, global and other regulatory inspections

Multiple Clients• Operational function improvement, process, procedure and document creation, and support.• Human Resource training and documentation.• New employee training and management.• Editorial and proof reading. • Regulatory compliance.• Project and vendor management. • Customer Service management, review and improvement.• New product development.

•Managed all Operational, Regulatory, and Quality programs.•Ensure product and document compliance with regulatory agencies.•Launched new call center and trained call representatives.•Created all documentation for regulatory compliance, training, and Human Resources.•Managed inventory and budget, vendor relations, product and project launches.•Obtained and maintained product testing, specifications, and technical information for products.

•Managed quality and regulatory programs, cross-functional teams, and vendors for adherence to Standard Operating Procedures (SOPs) used both internally and externally.•Managed product launch process with proven track record for completion and improvement.•Provided strategic council associated with marketing claims and avenues. •Prepared, reviewed and adjusted annual business plan and budget of more then $400k. •Created and trained internal staff for annual regulatory training.

•Created and implemented policy for contract manufacturing and independent testing programs.•Provided regular analysis for the quality and product launch functions for Senior Management. •Negotiated costs and timing for lab turnaround including bulk volume discounts. •Established protocol for dealing with out of spec products and other quality issues.•Initiated and developed customer service training program to increase profitability.

•Developed new nutritional supplement products. Coordinated between doctors, formulators, manufacturers, and marketers for new product idea, development, labeling, and finished product. •Completed and documented scientific research on ingredients and claims.•Worked with marketing departments to help develop sales strategies for new products.