Sr Auditor, Clinical Quality Assurance

Job Description
Provide support to all aspects of the Clinical Quality Assurance (CQA) function across the business. Support CQA Management in assuring quality throughout MicroVention and promote continual improvement processes to ensure all systems and procedures are compliant with Standard Operating Procedures (SOPs), regulations, standards, good clinical practices, and guidelines applicable to the medical device industry to contribute to overall quality and regulatory compliance objectives. Encompass a broad spectrum of responsibilities including conducting clinical research audits (sponsor, site, vendor, process, function, and systems); preparing for and hosting external regulatory inspections (e.g., mock BIMO, BIMO, for cause, etc.); and planning, execution, reporting, root cause analysis investigation, and closure. Provide comprehensive compliance direction to clinical study teams and cross-functional partners; ensuring clinical studies are conducted to the highest ethical and safety standards. Job duties:

• Act as a Subject Matter Expert (SME) for Clinical Quality issues and demonstrate ethics and integrity in matters at all levels of MicroVention.
• Attend assigned Clinical Research and Operations (CR&O) and cross-functional meetings.
• Implement global working practices and systems in compliance with SOPs, applicable laws, regulations, standards, good clinical practices, and guidelines applicable to the medical device industry.
• Identify gaps and develop and/or standardize operating policies, procedures, and tools that may have a global effect on processes and related critical documents.
• Drive a culture of prevention through risk identification, management, and mitigation to achieve the highest overall Clinical Quality standards.
• Develop and execute audit plans to support CQA initiatives.
• Plan and conduct Clinical Quality audits or projects that support the development or enhancement of objectives that may cross multiple regions, studies, functions, sites, and/or vendors with minimal supervision.
• Prepare and deliver audit reports for auditees and management by summarizing nonconformities/observations and opportunities for improvement and recommending courses of action, as appropriate.
• Complete root cause analysis investigations with auditees and assist CAPA owners with corrections, corrective, preventive, or verification of effectiveness actions.
• Contribute and/or lead presentations to provide CQA status updates, results, lessons learned, and/or recommendations to management and cross-functional partners.
• Work closely with management and relevant cross-functional partners to define and document project goals, milestones, and deliverables while influencing and supporting process improvements.
• Utilize critical thinking, analysis, expert knowledge, and advanced verbal/written communication skills to manage risks, address complex problems, and propose effective solutions.
• Provide effective training, coaching, and/or mentoring of clinical personnel on various aspects of clinical research studies while fostering an environment of open dialogue to address critical issues and/or escalations.
• Provide regulatory guidance during clinical investigation plan/protocol and informed consent development, finalization, and amendments.
• Provide review of critical documents, contracts, clinical data, analysis & storage, device disposition, safety, reporting, and training.
• Assist in establishing and maintaining metrics reporting to reflect effectiveness of Clinical Quality Assurance.
• Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate ethics and Integrity in all matters and at all levels throughout the organization.
• Perform additional duties as assigned.

Qualifications

1. Bachelor's degree in life sciences or related field.
2. Minimum of four (4) years of experience in clinical research and/or GCP related QA environment including auditing and/or external inspections (e.g., BIMO).
3. Minimum of (2) years project management skills, including the ability to develop, prioritize and manage project plans and approaches for global efforts.
4. In-depth understanding of global regulations and/or standards governing the conduct of clinical studies (e.g., 21 Code of Federal Regulations (CFR) Parts 11, 50, 54, 56, 812, 814, 820 and International Organization for Standardization (ISO) 14155 and 13485), Health Canada, EU MDR, ICH GCP (E6), GxP Guidelines and Regulations.
5. Advanced working knowledge of QA principles including Quality Risk Management (QRM), Critical Thinking, and Quality by Design (QbD).
6. Strong knowledge of compliance risks and quality controls.
7. Experience in adult education and/or training clinical research personnel.
8. Investigational medical device and/or neurovascular experience.
9. Advanced global IDE clinical medical device experience in all phases of studies, including development, execution, and closure.
10. Ability to concisely interpret clinical study results, safety reporting, data integrity, and metrics.
11. Advanced skills in strategic thinking, evaluating, and solving issues with varying degrees of complexity and ability to provide meaningful analysis output, recommendations, and information delivery to management.
12. Agile mindset and flexibility to meet changing needs and requirements for audit and/or inspections schedule.
13. Demonstrate strong commitment to compliance, ethics, and accountability.
14. Strong verbal and written communication skills, including strong technical writing skills.
15. Proficient MS Office skills to include Word, PowerPoint, Excel, and Teams.

Desired Qualifications

1. Proficient experience in auditing and external inspections.
2. Experience with EC/IRB/WIRB.
3. Ability to efficiently handle multiple tasks and effectively meet timelines.
4. Able to function independently within an environment that relies heavily on technology for communication and handling confidential information.