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.

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