Clinical Quality Assurance Manager: Outcome

Outcome is the leading provider of patient registries, studies, quality improvement programs, and integrated technologies for evaluating real-world outcomes. The company has designed, developed, and managed more than 150 patient registries, including many of the largest and most well-recognized programs for disease outcomes, comparative effectiveness and patient safety, and maintains its own EDC system in house.

Reports to: Senior Director of Quality

Responsibilities:

The Quality Assurance Manager is responsible for leading the Quality Assurance function at Outcome, including ensuring company compliance with clinical processes and regulations, performing internal and external audits and following up on findings, developing and maintaining Quality Management System documentation, and training personnel in areas related to compliance.

· Perform audits of internal processes and procedures to ensure staff compliance

· Perform quality audits of external vendors and partners to evaluate prospective groups and review ongoing work under contract

· Perform audits of project procedures, training, documentation and records.

· Implement programs and train personnel to ensure compliance with practices and procedures in support of company- wide programs such as ISO certification

· Develop and maintain quality management system documentation, including documents specific to regulatory and compliance processes and procedures

· Ensure compliance of procedures with application regulations

· Address process findings, issues and non-compliances from both internal and client audits, working with other groups as applicable

· Oversee internal training, including regulatory and compliance training of study personnel

· Serve as in-house consultant for understanding project-specific requirements regarding national, regional, local laws and regulations (e.g., privacy, data protection, ethics) and ensuring compliance

· Host client audits of Outcome, including presentation of the Outcome's Quality Management System and responding to questions.

Qualifications:

· Bachelor’s degree, preferred in scientific or health-related discipline

· Minimum of 4+ years of experience in the Quality field within the life sciences industry

· Knowledge of relevant healthcare and clinical regulatory environment standards and regulations, e.g., GCP, FDA, ICH

· Experience planning, performing and following up on process and documentation audits

· Experience developing and maintaining process documentation

· Proven ability to identify, document, address and resolve non-compliances

· Experience working in a structured, clinical regulatory environment

· Ability to understand and interpret national, regional and local regulations related to Outcome’s work

· Ability to develop training programs and successfully train personnel

· Ability to prioritize and schedule time for various activities such as audits considering business needs

· Ability to organize and track documentation and records