Quality Operations Manager – Contract
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Job Description
Quality Operations Manager supporting a CRO’s clinical quality systems, audits, vendor oversight, and FDA inspections. Reviewing study documents and regulatory guidance while partnering with operational teams.
Responsibilities:
- Support and, as applicable, implement quality operations initiatives supporting the company's quality management systems
- Collaborate with Project Management, Regulatory, Monitoring, Information Technology/Clinical Systems, Data Management, Biostatistics/Programming, and other operational staff on study document review, data reporting, site management issues, CAPA management, issue resolution, and database build/testing
- Review study documents, including protocols, informed consent form templates, study plans, CAPAs, and memo-to-files, for compliance with protocols, regulatory requirements, SOPs, and company and sponsor standards
- Support Quality Operations newsletters and create quality metrics trackers
- Support sponsor audits through preparation, interviews, presentations, document retrieval, audit calls/meetings, and audit finding responses
- Prepare, perform, and support internal eTMF and functional-area system audits
- Support contract compliance QA audits, including audit plans, document reviews, audit findings tables, and finding responses
- Provide training and managerial oversight support to the Quality Operations Associate; maintain training matrices and personnel training files
- Perform audits of clinical sites and clinical third-party vendors
- Report to the VP of Quality Operations on audit preparation, conduct, and follow-up
- Support FDA inspections, including readiness training, inspection attendance, subject matter expert interaction, document retrieval/review, and scribing
- Research FDA guidance and regulatory correspondence; maintain regulatory guidance tracking and notify CRO personnel of updates
- Support the company Quality Management Plan and quality deliverables, including SOPs, standard documents, work instructions, and training materials
- Provide Quality Operations support to core study teams on quality issue escalation, remediation, and study document review
- Facilitate and manage vendor audits and support vendor qualification/assessments
Requirements:
- Bachelor's degree, preferably in a scientific/healthcare field
- Minimum 5–7 years of experience in a related area
- Knowledge of FDA regulatory requirements
- Experience as a GCP-focused clinical QA Auditor preferred, or quality assurance experience via a clinical site, CRO, and/or sponsor
- Familiarity with clinical research concepts, practices, and procedures
- Strong writing, presentation, and communication skills
- Strong organizational, interpersonal, and teamwork skills
- Exceptional attention to detail
- Ability to enter data accurately and experience working with Microsoft Office
- Ability to handle multiple tasks simultaneously
- Ability to work in a home environment and travel environment
- Ability to travel as required by audit and inspection activities
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