QA and Compliance Manager

Position Summary

The QA and Compliance Manager is responsible for ensuring compliance with regulatory standards, quality management practices, and execution of clinical studies according to established protocols and contractual obligations.

Key Responsibilities

• Implements and maintains quality assurance policies and procedures.
• Conducts regular audits of clinical trial activities to ensure compliance with regulatory requirements and internal standards.
• Oversees the management of adverse event reporting and compliance documentation.
• Supervises the management and implementation of Standard Operating Procedures (SOPs) to ensure compliance and operational efficiency.
• Establishes, measures, and reports on quality indicators.
• Trains staff on quality assurance practices and compliance regulations.
• Collaborates with cross-functional teams to address quality-related issues and implement corrective actions.
• Supports site staff during sponsor monitoring, audit activities, and health authority inspections including preparation, hosting, and resolution of any items.
• Serves as a point of contact for regulatory agencies during inspections and audits.
• Leads investigations into quality deviations and develop action plans to prevent recurrence.
• Perform other duties as assigned.

Skills/Abilities

• Well-versed in the conduct of clinical trials.
• Subject matter expert of ICH/GCP, regulatory requirements, and FDA and HIPAA policies and practices.
• Experienced in FDA inspections and sponsor audits.

Education/Experience

• Bachelor's degree in a related field or relevant experience required.
• CCRC, ACRP, or compliance certification preferred.
• 2+ years of CRC experience required.
• 3+ years of quality specialist experience required.
• 1-2 years of quality management experience required.

Additional information

Position is fully remote, but will require occasional site travel (20%). Candidates must be located in Eastern or Central zones for consideration.