Audit and Inspection Specialist

Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the CureTM. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to humankind. We have supported many of the most impactful new drug approvals in oncology, and we are seeking the most talented individuals globally that are passionate in their desire to assist us in our mission to customize each clinical trial’s imaging to optimize the opportunity to demonstrate efficacy.

Imaging Endpoints is based in Scottsdale, Arizona, with offices in Cambridge, Massachusetts; London, UK; Leiden, Netherlands; Basel, Switzerland; Hyderabad, India and Shanghai, China. We are an affiliate of HonorHealth, one of the largest healthcare systems nationally, and Scottsdale Medical Imaging Limited (SMIL/RadPartners), the largest private radiology group in the United States. We are recognized as the world’s largest and most preeminent iCRO in oncology.

The Audit and Inspection Specialist is responsible for planning, coordinating, and supporting all pre-audit, audit conduct, and postaudit/inspection activities for all external audits and regulatory inspections at Imaging Endpoints. The Audit and Inspection Specialist ensures that the organization maintains compliance with global regulatory requirements and sponsor expectations by serving as the internal primary liaison before, during, and after audits and inspections conducted by external customers, their designees, and/or regulatory authorities.

AUDIT AND INSPECTION SPECIALIST

RESPONSIBILITIES

• Act as Audit/Inspection backroom lead and perform pre-audit, audit conduct, and postaudit/
• inspection backroom activity management.
• Serve as the primary internal point of contact for all external audits and regulatory inspections
• hosted or supported by Imaging Endpoints, to include the entire Audit/Inspection lifecycle.

Pre-Audit/Inspection Activities

• Support continuous improvement of the audit and inspection program to ensure organizational preparedness at all times.
• Coordinate pre-audit activities including (but not limited to), assigning and monitoring preaudit/ inspection tasks by stakeholders, TMF document review, SME training, audit agenda planning, performance metrics, and billing management.

Audit/Inspection Conduct Activities

• Manage and oversee backroom activities ensuring effective task delegation, efficient task execution and timely fulfilment of auditor/inspector requests.
• Manage and oversee the accurate and timely documentation/tracking of auditor/inspector requests and turnaround times in support of performance metrics.
• Manage real-time issue resolution during audits and inspections.

Post-Audit/Inspection Activities

• Lead the development of responses to audit and inspection findings in collaboration with internal stakeholders.
• Track and ensure timely completion of corrective and preventive actions (CAPAs) associated with audits and inspections.
• Maintain audit and inspection records in compliance with company SOPs and regulatory requirements.
• Monitor CAPA effectiveness and escalate delays and/or risks.
• Prepare audit summary reports and lessons-learned documentation.

Compliance & Continuous Improvement

• Monitor trends in audit findings and regulatory expectations to drive continuous improvement initiatives.
• Provide training and guidance to internal teams on audit readiness and regulatory compliance.
• Support internal quality initiatives to align with GCP, ICH guidelines, and applicable imaging standards.

EDUCATION AND EXPERIENCE

• Bachelor’s degree in pharmaceutical sciences or other related scientific disciplines.
• Minimum four (4) years of experience in a regulated industry with at least two (2) years of experience in pharmaceuticals and/or medical devices.
• Imaging Core Lab and/or Contract Research Organization experience preferred.
• Knowledge and understanding of 21CFR Part 211, 21CFR Part 312, ISO 13485, and Good
• Clinical Practices (ICH E6 GCP), Good Documentation Practices (GDP), and Good Manufacturing Practices (GMPs).
• Proven experience hosting external audits and regulatory inspections (FDA, EMA, MHRA, etc.).
• Familiarity with risk-based quality management principles.
• Certification in auditing (e.g., ASQ CQA) or regulatory compliance is a plus.
• Good working knowledge of CAPA / deviation processes, investigational methodologies, and procedures.
• Solid working knowledge of audit practices, strategies, and principles.
• Proficiency in MS Office and internet applications.

SKILLS

• Excellent organizational and project management skills.
• Strong communication and interpersonal skills for effective interaction with sponsors, regulators, and internal teams.
• Ability to work under pressure and manage multiple priorities during high-stakes audits.
• Demonstrated flexibility and ability to work effectively across multiple time zones to support global audit activities.
• Ability to manage priorities and collaborate with stakeholders across various regions and time zones.
• 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.
• Ability to motivate others and facilitate a positive work environment.
• Ability to manage projects and deliverables with a high level of accuracy and completeness.
• Ability to work independently with minimal supervision.
• Excellent hands-on computer skills with thorough knowledge of Microsoft Office to include Word,
• Excel, and Power Point.

IMAGING ENDPOINTS’ TEAM CHARACTERISTICS

• Passion to Connect Imaging to the CureTM and pursue a meaningful career by improving the lives of cancer patients through imaging
• Strong desire to be part of a dynamic, global team working closely together and growing year after year in a rewarding environment to help humanity through imaging
• Commitment and caring for our fellow team members, their families, and the communities IE serves - see Caring Endpoints
• Integrity and high ethical standards; we always do the right thing
• High intellect and ingenuity; we enjoy solving problems, finding a better way, and the challenge of making a difference by improving lives
• Structured, organized, detail-oriented, and self-motivated; we approach each day with a detailed plan and excitement to accomplish the day’s objectives while striving to improve ourselves and IE everyday
• Accountable; we do what we say and communicative effectively to meet deadlines; we enjoy advancing clinical trials, helping patients, and celebrating success
• High standard for excellence; we proof our own work, hold high standards for ourselves and our team, and always prioritize quality above all else

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: Estimated up to 10% travel (domestic and international)