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.
About Us
At Rovia Clinical Research, we’re on a mission to bring innovative treatments to patients, improving the health and lives of our local patient communities. We believe in building a workplace where people feel supported, valued, and excited to grow their careers. Whether you’re just starting out or looking for a new path, you’ll be part of a team that truly works together and makes an impact. Our team is driven by our core values: People First, Humility, Integrity, One Team, and Results Accountability.