PURPOSE
The Quality Operations Manager reports to Vice President (VP) Quality Operations and is responsible for supporting and as applicable, implementing quality operations initiatives to support the company’s quality management systems. At the request of Sr. Quality management, may be required to collaborate directly with Project Management, Regulatory, Monitoring, Information Technology/Clinical Systems, Data Management, Biostatistics/Programming and/or other operational staff on study document review, data reporting, site management issues, CAPA management, issue resolution, and database build/testing.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Employee performs all, part, and/or any combination of the duties listed below.
• Review study documents and provide feedback on protocols, Informed Consent Form templates, study plans, CAPAs, memo-to-files, and others as necessary for the purpose of evaluating compliance to protocol, applicable regulatory requirements, SOPs, and applicable Lotus and sponsor standards.
• Provide support with content for Quality Operations newsletters to CRO operational staff.
• Responsible for creating (as applicable) quality metrics trackers to support CRO quality initiatives. Works directly with VP of Quality Operations to establish metrics when necessary.
• Support Quality Operations management with sponsor audits, including but not limited to preparation, interviews, creation of quality Operations presentations, review of other functional area presentations, attendance during audit calls/meeting, document retrieval, audit finding responses.
• Prepare, perform, and/or support completion of internal eTMF audits.
• Prepare, perform, and/or support completion of internal driven functional area system audits. May include support for contract compliance QA Auditor, preparing audit plans, communication with functional area management, requesting of general and/ or study specific documents for review, access and review of documents within the study eTMF, preparing report and/or audit findings table, and issuance/review of finding responses.
• Provide support and direct managerial duties for the Quality Operations Associate in preparing and conducting company training as it relates to quality operation initiatives to company personnel and ensuring Company Training Matrix and personnel training files are current, accurate, and complete.
• Perform audits of clinical sites and/or clinical third-party vendors in support of quality assurance initiatives and clients contract requirements. Will report directly to the VP Quality Operations on activities associated with the preparation, conduct, and follow-up related to any audits performed.
• Support VP Quality Operations and senior operations staff with FDA Inspections including but not limited to readiness training, attending the inspection, interaction with subject matter experts, document retrieval/review, and acting scribe.
• Maintain an up-to-date understanding of issues and changes in regulatory compliance activities at FDA and other regulatory agencies. Will conduct ongoing research of FDA guidance’s and information correspondence to keep informed and disseminate latest regulatory information. Will maintain Quality Operations Regulatory Guidance tracking and notifying all CRO personnel of new/updated guidance which may govern CRO contract services
• Support quality initiatives as outlined in company Quality Management Plan.
• Support quality deliverables associated with company infrastructure including, but not limited to, SOP development/review, Standard Document development/review, company Work Instruction development/review and training development/review.
• Maintain a high level of knowledge and understanding of protocols, study plans, and other applicable study documents. May be requested to provide Quality Operations support to Lotus core study team members as it relates to quality issue escalation, remediation, and/or other support throughout a clinical study, including the review of study protocols, Informed Consent Forms, and Clinical Study Reports.
• Support the facilitation of and management of vendor audits. May be required to collaborate with consultant QA Auditors on vendor qualification/assessments if not performing the audit directly.
• Maintain good working knowledge of Clinical Research procedures and guidelines.
SUPERVISORY RESPONSIBILITIES
Position does not have supervisory responsibilities, although at the direction of the VP of Quality Operations, may provide training and/or managerial oversight to the Quality Operations Associate.
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
EDUCATION and/or EXPERIENCE
• Bachelor’s degree, preferably in a scientific/healthcare field with minimum 5-7 years of experience in related area. Knowledge of FDA regulatory requirements is required.
• Experience as a GCP focused clinical QA Auditor is preferred, or at a minimum, quality assurance experience via clinical site, CRO, and/or sponsor
• Familiar with a variety of concepts, practices and procedures in clinical research. Strong writing, presentation, and communication skills. Works effectively and efficiently to handle multiple tasks simultaneously with strong organizational skills. Ability to facilitate a teamwork philosophy.
S KILLS and/or ABILITIES
• Ability to enter data accurately including experience working with Microsoft Office. Ability to work effectively and efficiently handling multiple tasks simultaneously. Ability to facilitate a teamwork philosophy with a positive attitude. Strong interpersonal skills. Exceptional attention to detail. Excellent organizational skills.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
Work in a home environment where the noise level is usually largely controlled by the employee, and a travel environment where the noise level is usually moderate to high. Employee is subject to many interruptions; pressure due to deadline requirements; and handling multiple tasks simultaneously while performing assigned duties.