Senior Director, Operational Compliance
Scottsdale, AZ, USA | Imaging Endpoint
Industry:Pharmaceutical / Biotech
Legal / Compliance
Job Description:57 people have viewed this job
Imaging Endpoints (IE) is an Imaging Clinical Research Organization (iCRO) that also provides comprehensive CRO and Site Management Organization (SMO) services. We are based in Scottsdale, Arizona, with an office in Waltham, Massachusetts. We are an affiliate of HonorHealth, one of the largest healthcare systems nationally. Additionally, IE is an affiliate of Scottsdale Medical Imaging Limited (SMIL/SDI), one of the largest private radiology groups in the U.S. We operate in over twenty countries globally and are recognized as the preeminent iCRO for complex trials, particularly within oncology.
The primary responsibility of the Senior Director, Operational Compliance is to direct areas of quality assurance (QA) related to Imaging Endpoints’ (IE) Core Lab operational activities. The Senior Director, Operational Compliance will be solution-oriented, facilitate timely quality decisions, and meet the needs of the business and all stakeholders with respect to quality assurance principles and practices.
• Lead and manage IE’s Operational Compliance team to ensure adequate compliance to relevant QMS and study related procedures.
• Support the implementation and maintenance of study related documentation to meet regulatory and business requirements.
• Provide operational support with respect to the regulations governing clinical research, investigational products, and quality standards, specifically, 21 CFR Part 312, 21 CFR Part 211, ICH E6, and ISO standards.
• Manage, in conjunction with the Compliance and Regulatory Affairs Management team, the development and maintenance of a 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 Chief Compliance and Regulatory Affairs Officer to implement operational compliance strategies and plans to facilitate continuous improvement as it relates to IE and sponsor projects.
• Perform proposal review.
• Responsible for Compliance review of study set-up activities.
• Act as liaison to Imaging Operations for study related activities (e.g., internal and external kick off meetings, primary contact for discrepancies and operational issues, first responder escalation for study specific questions.)
• Responsible for the quality of study 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 operational compliance.
• Provide quality oversight and input regarding discrepancy reporting such as non-conformances, and deviations, originating within Imaging Operations to sponsor projects and/or IE’s QMS.
• Provide support to Compliance and Regulatory Affairs Management to ensure the effectiveness of IE’s discrepancy management program (e.g., CAPA inputs and deviations).
• Provide input to Compliance and Regulatory Affairs Management in support of IE’s vendor management program.
• Provide input to Compliance and Regulatory Affairs Management in support 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.
• Interact with sponsors to ensure adequate quality 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 operational compliance and sponsor projects.
• Interface with Compliance and Regulatory Affairs to develop robust and compliant operational 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.
• Assist in post-study readiness for investigational projects to ensure developmental work complies with GxP quality principles and regulatory expectations.
• Support document change management program via review and approval of QMS and study documentation.
• Approval of interim and final study variability reports.
• Ensure proper control, retention, and archival of documents managed under GxPs.
• Provide input to Compliance and Regulatory Affairs Management in support of the establishment and implementation of 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 guidance documents).
• Perform other duties as assigned by supervisor.
EDUCATION AND EXPERIENCE
• Bachelor’s degree in pharmaceutical sciences or related scientific disciplines.
• Minimum seven (7) years of experience in regulated industries with at least three (3) years in pharmaceuticals, medical device, or clinical research.
• Imaging Core Lab experience desired.
• Knowledge of 21CFR Part 211 (cGMP), ISO standards, ICH E6, 21CFR 11, and FDA current thinking and interpretation of regulations and guidelines.
• Understanding of the requirements of 21CFR Part 312.
• Validation knowledge and experience in the review and approval of equipment, utilities qualification, 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 preferred.
• Experience in operational compliance, preferred.
• Quality risk management experience a plus.
• Proficiency in MS Office and internet applications.
• 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.).
• 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.
• Estimated 10-20% travel (domestic and international)
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