QA and Compliance Manager

Rovia Clinical Research; United States; Remote; USD 110,000 - 160,000; Full time

Job summary

Rovia Clinical Research is seeking a QA and Compliance Manager to ensure regulatory and quality standards across clinical studies. The role focuses on audits, SOP oversight, adverse event reporting, and training staff in QA practices.

You will lead investigations into deviations and work with sponsor monitors and inspectors. The position is fully remote with occasional site travel (approximately 20%), and candidates located in the Eastern or Central zones are preferred.

Qualifications

• Strong knowledge of ICH/GCP, FDA regulations and HIPAA policies.
• Experience conducting audits and managing quality systems in clinical trials.
• Ability to lead investigations, corrective and preventive actions.

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 adverse event reporting and compliance documentation.
• Manages SOPs to ensure compliance and efficiency.
• Establishes and reports on quality indicators.
• Trains staff on QA practices and regulatory regulations.

Skills

ICH/GCP knowledge

FDA inspections experience

Regulatory compliance

Quality_management

Education

Bachelor's degree in life sciences or related field

Compliance certification preferred

Job description

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.