Location: Boston, MA

Ideal Candidate:
5+ to 7 years of experience
Management Experience Required – No
Minimum Education – Bachelor’s Degree

Willingness to Travel – Occasionally

The company is looking for a Clinical Quality Assurance Manager to perform and manage internal, client and vendor audits; write, edit and manage Quality System documentation; provide training to internal staff; manage the CAPA process; develop and report on quality metrics; and provide input on industry best practices.

Specific Responsibilities:

-Develop and maintain quality management system documentation, including documents specific to regulatory and compliance processes and procedures
-Oversee internal training, including regulatory and compliance training of study personnel
-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
-Develop and implement quality programs including training personnel to ensure compliance with practices and procedures in support of company- wide quality programs such as ISO certification
-Ensure compliance of procedures with applicable regulations
-Manage the CAPA process to address findings, issues and non-compliances from both internal and client audits, working with other groups as applicable
-Host client audits of our company, including presentation of our company’s Quality Management System and responding to questions
-Deliver trainings as required on QMS processes and procedures
-Maintain internal training records and ensure timely compliance with company and job specific training requirements
-Develop, maintain and report on quality metrics related to compliance, training effectiveness and resolution of issues including CAPAs and audit findings
-Provide in-house guidance on the application of national, regional and local laws and regulations (e.g., privacy, data protection, ethics) to project-specific requirements and ensuring compliance

Qualifications:
-Minimum of 4+ years of experience in the Quality field within the life sciences industry
-Knowledge of relevant healthcare regulatory environment standards and regulations, for example GCP, FDA, ICH, other organizations
-Experience working in a structured environment
-Experience performing process and documentation audits
-Experience developing process documentation
-Proven ability to address and resolve non-compliances
-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
-Ability to understand and interpret national, regional and local regulations related to our company’s work
-Bachelor’s degree, preferred in scientific or health-related discipline