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Manager – Quality Management System

Imaging Endpoint

This is a Full-time position in Scottsdale, AZ posted October 31, 2021.

Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO) that also provides comprehensive Site Management Organization (SMO) services.

We are based in Scottsdale, Arizona, with an office in Waltham, Massachusetts and are an affiliate of HonorHealth, one of the largest healthcare systems nationally.

Additionally, IE is also an affiliate of Southwest Medical Imaging Limited (SMIL/RadPartners), the largest private radiology group in the U.S.

We operate in over thirty-five countries globally and are recognized as the preeminent iCRO for complex trials, and one of the world’s largest iCROs in oncology.

JOB DESCRIPTION

The QMS Manager is responsible for managing IE’s QMS on a professional level and works closely with Compliance management and the Chief Compliance and Regulatory Affairs Officer to support and maintain IE’s Quality Management System.

This position is responsible for the managing the QMS areas as described in the responsibilities section below

RESPONSIBILITIES

• Lead and manage IE’s QMS team to ensure adequate quality systems are implemented and maintained across the business to meet quality requirements.

• Provide quality system management within the regulations of clinical research, investigational products and quality standards, specifically, 21 CFR Part 312, 21 CFR Part 211, and ICH E6 (R2); and provide direct QA support related to the Imaging Endpoints QMS.

• Develop and maintain robust iCRO quality oversight program.

• QA responsibilities include but are not limited to GXP documentation review and approval for procedures related to IE’s Imaging Core Lab QMS and process controls.

• Responsible for engaging strong intradepartmental, cross-functional and organizational relationships to drive quality system requirements.

• Interface with the Compliance management to implement quality system strategies and plans to facilitate continuous improvement of the QMS as it relates to IE and sponsor projects.

• Responsible for the quality of QMS documentation approved to support GxP activities for IE and sponsor related projects.

• Interface with other areas of the organization to provide sound QA decision-making in areas that impact the QMS.

• Provide quality oversight and input regarding discrepancy reporting such as non-conformances, and deviations related to sponsor projects and/or IEs’ QMS; and provide final disposition of discrepancies that impact IEs’ QMS.

• Ensure effectiveness of the discrepancy management program (e.g., CAPA and deviation management).

• Oversee and ensure effectiveness of the vendor management program.

• Oversee and ensure effectiveness of the internal audit program.

• Oversee and ensure effectiveness of the QMS training program.

• Interact with regulatory agencies and sponsors when needed, and facilitate good conduct of inspections and audits by communicating effectively, effective preparation of documentation, training of staff, and providing accurate information.

• Ensure adequate QMS infrastructure is maintained for sponsor projects; this includes meeting regulatory, international, and industry standards related to GxP activities.

• Establish and report quality metrics related to the IE QMS and sponsor projects.

• Interface with Regulatory Affairs and Operational Compliance to develop robust compliance processes.

• Ensure audit and inspection readiness by training staff and implementing readiness initiatives.

• Generate responses to inspectional findings and audits, as applicable.

• Develop action plans to address FDA inspectional findings and sponsor audit findings.

• Manage action plans to closure and report results to management and sponsor representatives.

• Oversee change management program.

• Manage and report on the change control process and all activities related to preparation, review, approval, and deployment of controlled documents.

• Ensure proper control, retention, and archival of documents managed under GxPs.

• Establish and implement QA procedures and controls to develop a compliant Core Lab QMS.

• Review and approve various reports related to qualification activities and study reporting.

• Maintain high performing compliance staff by recruiting, orienting and training employees.

• Maintain professional working knowledge of relevant regulations, guidance documents, and standards (e.g., FDA Title 21, ICH quality standards, FDA and global guidance documents).

• Oversee and maintain QMS to ensure current industry standards are applied within IEs’ QMS.

• Perform other duties as assigned by supervisor.

EDUCATION AND EXPERIENCE

• Bachelor’s degree in one of the pharmaceutical sciences or related scientific disciplines.

• Minimum seven (7) years of experience in regulated industries with at least three (3) years in pharmaceuticals or medical device and (3) years performing at a management level or higher.

• Imaging Core Lab experience desired.

• Working knowledge of MasterControl or other eDMS preferred

• Knowledge of ICH E6 GCP, 21 CFR Part 211 (cGMP), ISO 13485, 21 CFR 312, GDPR, and FDA current thinking and interpretation of regulations and guidelines.

• Understanding of the requirements of 21 CFR Part 312.

• Validation knowledge and experience in the review and approval of process validation and software validation reports.

• Good working knowledge of CAPA and deviation processes and procedures.

• Experience in preparation and/or review of documents submitted to FDA for review.

• QMS experience in a regulated industry required.

• Quality risk management experience preferred.

• Proficiency in MS Office and internet applications

SKILLS AND ATTRIBUTES

• Work precisely and in compliance with all procedures, rules and regulations.

• Must maintain strict confidentiality of sensitive data, records, files, conversations, etc.

• Excellent interpersonal, organizational and communication skills, including oral and written.

• Self-motivated and able to grasp new concepts and learn quickly as well as motivate others.

• Ability to manage projects and deliverables with a high level of accuracy and completeness.

• Ability to work independently with little supervision.

• Excellent hands-on computer skills with thorough knowledge of Microsoft Office to include Excel and Power Point (statistics, graphing, presentations, etc.).

PHYSICAL REQUIREMENTS

• While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk and hear.

The employee is frequently required to sit.

Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.

TRAVEL REQUIREMENTS

• 10% – 20% travel (Domestic and International)

Imaging Endpoints is an equal opportunity employer.

All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status