Job Title: Quality Operations Manager for the CRO (GCP)
Department: Quality Operations
Location: Remote, west coast preferred
Job Description
The Quality Operations Manager reports to the Vice President ofQuality Operations and is responsible for supporting and as applicable, implementing quality operations initiatives to support the companys quality management systems. At the request of Sr. Quality management, may be required to collaborate directly with Project Management, Regulatory, Monitoring, Information Technology, and/or other operational staff on study document review, data reporting, site management issues, CAPA management, issue resolution, and database build/testing.
Responsibilities
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May 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.
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Responsible for creating (as applicable) quality metrics trackers to support CRO quality initiatives. Works directly with Head of Quality Operations to establish metrics when necessary.
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Supports Sr. Quality Operations management with sponsor audits, including but not limited to preparation, attendance during audit calls/meeting, document retrieval, audit finding responses.
- May prepare, perform, and/or support completion of internal eTMF audits.
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Prepares, performs, and/or supports completion of internal functional area system audits. May include 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.
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May provide support in preparing and conducting company training as it relates to quality operation initiatives to company personnel.
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May 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 Head of Quality Operations on activities associated with the preparation, conduct, and follow-up related to any audits performed.
- Supports Sr. Quality Operations management with FDA Inspections including readiness training, and acting scribe.
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Maintains an up-to-date understanding of all issues and changes in regulatory compliance activities at FDA and other regulatory agencies. Will conduct ongoing research of FDA guidances and information correspondence to keep informed and disseminate latest regulatory information. Has experience in performing quality assurance audits.
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Maintains a high level of knowledge and understanding of all protocols, study plans, and other applicable study documents. May be requested to review and complete documentation supporting Quality Operations review of study protocols, Informed Consent Forms, and Clinical Study Reports.
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Supports 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.
- Maintains good working knowledge of Clinical Research procedures and guidelines.
Supervisory Responsibilities
Position does not have supervisory responsibilities, although at the direction of the Quality Operations Head, may provide training and/or direction 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/Experience
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Bachelors 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 highly preferred.
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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.
Skills and Abilities
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Ability to enter data into PC 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.
