Quality Operations Manager – Contract

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist and, where applicable, execute quality operations initiatives that support the company's quality management systems.

• Collaborate with Project Management, Regulatory, Monitoring, Information Technology/Clinical Systems, Data Management, Biostatistics/Programming, and other operational teams on reviewing study documents, reporting data, addressing site management issues, managing CAPAs, resolving issues, and database development/testing.

• Assess study documents, such as protocols, informed consent form templates, study plans, CAPAs, and memos, to ensure compliance with protocols, regulatory standards, SOPs, and both company and sponsor guidelines.

• Assist in the creation of Quality Operations newsletters and develop quality metrics trackers.

• Facilitate sponsor audits by preparing for proceedings, conducting interviews, delivering presentations, retrieving documents, participating in audit calls/meetings, and responding to audit findings.

• Prepare, execute, and support internal electronic Trial Master File (eTMF) and functional area system audits.

• Aid in contract compliance quality assurance audits, including planning audits, reviewing documents, compiling audit findings tables, and responding to findings.

• Provide training and managerial oversight to the Quality Operations Associate; keep training matrices and personnel training files updated.

• Conduct audits of clinical sites and third-party clinical vendors.

• Report to the VP of Quality Operations on audit preparation, execution, and follow-up activities.

• Support FDA inspections, including readiness training, presence during inspections, interactions with subject matter experts, document retrieval/review, and scribing.

• Research FDA guidance and regulatory correspondence; maintain tracking of regulatory guidance and inform CRO personnel of any updates.

• Contribute to the company’s Quality Management Plan and quality deliverables, including SOPs, standard documents, work instructions, and training materials.

• Provide Quality Operations support to core study teams for quality issue escalation, remediation, and document review.

• Coordinate and manage vendor audits and assist with vendor qualification/assessment processes.

⛳️ Requirements

• Bachelor's degree, preferably in a scientific or healthcare discipline.

• A minimum of 5–7 years of experience in a relevant field.

• Familiarity with FDA regulatory requirements.

• Experience as a GCP-focused clinical QA Auditor is preferred, or quality assurance experience within a clinical site, CRO, and/or sponsor.

• Understanding of clinical research concepts, practices, and procedures.

• Proficient writing, presentation, and communication skills.

• Strong organizational, interpersonal, and teamwork abilities.

• Exceptional attention to detail.

• Capability to enter data accurately and experience with Microsoft Office.

• Ability to manage multiple tasks simultaneously.

• Comfortable working in both home and travel environments.

• Willingness to travel as necessary for audits and inspections.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health insurance plans.

• Opportunities for professional development and training.

• Flexible work arrangements.

• Supportive and collaborative work environment.