QA and QMS Development

• Author, review, evaluate and implement documentation and documentation systems (GXP procedures, policies, quality manuals, protocols, reports, and related forms, and specifications). 

• Phase-appropriate, product-specific QS development. 

• Develop, evaluate, and conduct training programs and/or systems for personnel operating in GLP, GCP, GDocP, GMP, GDistP, and GVP environments. 

• GXP audits – review/audit internal systems and perform initial, ongoing, and for-cause audits of vendors and service providers to ensure compliance, appropriateness, and adequacy of systems and processes. 

• Review and approval of GXP documents for compliance to relevant regulations, guidelines and Industry practice, including written procedures for consistency, accuracy, appropriateness, and readability. 

• Track and monitor deviations from critical processes to ensure that compliance issues are resolved and corrected. 

• Work with the product development team to establish quality standards and monitor manufacturing parameters for process improvement. 

• Ensure that employees working in regulated areas are appropriately trained and aware of and promote quality requirements that are essential to a culture of quality. 

• Provide regular written feedback/reports to Management regarding the status of the QS, including outsourced products and services including continuous improvement metrics. 

• Continuous process improvement planning and implementation. 

• Review and evaluation of product return and recall information to identify specific problems or trends over time. 

• FDA (regulatory) Quality Metrics development and reporting.

• Compliance program development and oversight.