QA and Compliance Manager

ROVIA; United States; Remote; USD 90,000 - 125,000; Full time

Job summary

Rovia Clinical Research is seeking a QA and Compliance Manager to ensure that our clinical studies meet regulatory standards and contractual obligations. You will lead quality assurance programs and drive continuous improvement across trial activities, documenting findings and action plans.

The role is fully remote with occasional site travel (20%). The candidate should have strong knowledge of ICH/GCP, FDA/HIPAA policies, and relevant certifications. Eastern or Central time zones preferred.

Qualifications

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

Responsibilities

• Implements and maintains QA policies and procedures.
• Audits clinical trial activities for regulatory compliance.
• Oversees adverse event reporting and compliance docs.
• Manages SOPs to ensure compliance and efficiency.
• Establishes, measures, and reports quality indicators.
• Trains staff on QA practices and regulations.
• Collaborates with cross-functional teams for corrective actions.
• Supports sponsor monitoring, audits, and inspections.
• Acts as regulatory liaison during inspections.
• Leads investigations into deviations and prevents recurrence.
• Performs other duties as assigned.

Skills

Clinical trials

ICH/GCP

FDA compliance

HIPAA

Education

Bachelor's degree in related field

ACRP certification

CCRC

Job description

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.

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.