QA and Compliance Manager

About the Company

Rovia Clinical Research is focused on advancing new therapies that improve the well-being of patients and strengthen the communities it serves. The organization emphasizes a collaborative culture where employees feel supported, respected, and motivated to develop professionally. Its work is guided by five core principles: putting people first, staying humble, acting with integrity, operating as one team, and being accountable for results.

Role Overview

The QA and Compliance Manager will ensure clinical research activities align with applicable regulatory standards, quality systems, protocol requirements, and contractual commitments. This role is central to maintaining compliance, strengthening quality processes, and supporting successful study execution.

Core Responsibilities

• Develop, implement, and maintain quality assurance policies and procedures.
• Review clinical trial activities through routine audits to confirm adherence to regulatory expectations and internal quality standards.
• Oversee adverse event reporting and the upkeep of compliance-related records and documentation.
• Manage the use and continuous improvement of Standard Operating Procedures to support compliance and efficient operations.
• Define, track, and report quality metrics and indicators.
• Provide training to staff on quality assurance practices and compliance obligations.
• Work with cross-functional partners to resolve quality issues and carry out corrective actions.
• Assist site teams during sponsor monitoring visits, audits, and health authority inspections, including preparation, hosting, and follow-up resolution.
• Act as a contact point for regulatory agencies during inspections and audits.
• Investigate quality deviations and create preventive action plans to reduce repeat issues.
• Carry out additional tasks as needed.

Required Skills and Expertise

• Strong understanding of clinical trial operations.
• Advanced knowledge of ICH/GCP standards, regulatory expectations, and FDA and HIPAA rules and practices.
• Hands-on experience supporting FDA inspections and sponsor audits.

Education and Experience

• Bachelor’s degree in a relevant discipline or equivalent practical experience.
• CCRC, ACRP, or another compliance-related certification is preferred.
• At least 2 years of CRC experience.
• At least 3 years of experience in a quality specialist role.
• 1 to 2 years of quality management experience.

Work Arrangement

This is a fully remote position with occasional travel to sites, expected to account for about 20% of the role. For consideration, candidates must be based in the Eastern or Central time zones.