SR. QA/RC AUDITOR, DCRI

Position Summary

Performs a variety of activities involved in evaluating the extent to which clinical research processes and documentation are aligned with applicable regulations and study-specific requirements. These evaluation activities are the foundation of DCRI's audit program. Additionally, this position involves other general quality management activities.

** NOTE: This position may have an opportunity to work remotely. All Duke University and Duke Health remote workers must reside in one of the following states or districts: Arizona; California; Florida; Georgia; Hawaii; Illinois; Maryland; Massachusetts; Montana; New Jersey; New York; North Carolina; Pennsylvania; South Carolina; Tennessee; Texas; Virginia or Washington, DC.

Primary Responsibilities and Tasks

Audit Activities

• Independently plan, conduct and manage all audit related activities for internal audits, vendor audits, and clinical site audits; Independently plan, facilitate, and manage all audit related activities related to sponsor audit and regulatory inspection facilitation (details following by audit type).

Internal Audits

• Plan and conduct internal audits to ensure that studies are conducted in accordance with sponsor protocols, standard procedures, GCP, appropriate regulations and guidance. Evaluate maintenance of documentation against the applicable regulatory standards and contractual obligations. Prepare and distribute audit reports.
• Prepare and distribute Audit Observation Reports to the auditees, review and assess observation responses and when applicable, Corrective and Preventive Action (CAPA) plans provided by the auditees. Continue follow up with the auditees until Audit Observation Reports are completed and closed.

Vendor Audits

• Plan and conduct external audits of subcontractors for the purpose of vendor evaluation, including due diligence review, vendor audits, and periodic re-evaluations. Prepare and distribute audit reports.
• Prepare and distribute Audit Observation Reports to the auditees, review and assess observation responses and when applicable, Corrective and Preventive Action (CAPA) plans provided by the auditees. Continue follow up with the auditees until Audit Observation Reports are completed and closed.

Site Audits

• Plan and conduct clinical site audits to ensure that studies are conducted in accordance with sponsor protocols, standard procedures, GCP, appropriate regulations and guidance. Evaluate maintenance of documentation against the applicable regulatory standards and contractual obligations. Prepare and distribute audit reports.
• Prepare and distribute Audit Observation Reports to the auditees, review and assess observation responses and when applicable, Corrective and Preventive Action (CAPA) plans provided by the auditees. Continue follow up with the auditees until Audit Observation Reports are completed and closed.

Sponsor Audits

• Plan and facilitate sponsor audits. Serve as primary interface with sponsor auditor(s). Create and provide the audit agenda to the auditor(s) and internal participants. Conduct pre-audit meeting to aid in audit preparation for the auditees.
• Provide sponsor audit observations to the internal auditees, collect observation responses and action commitments (CAPA) from all involved in audit, send the responses to the sponsor on a timely manner and by the due date.
• Continue follow up with the auditees until observation responses and CAPA commitments are completed and closed

Regulatory Inspections

• Plan and facilitate regulatory inspections. Serve as primary interface with inspector(s). Create and provide the inspection agenda to internal participants. Conduct pre-audit meeting to aid in inspection preparation for the auditees.
• Provide inspection findings to the internal auditees, collect inspection responses and action commitments (CAPA) from all involved in the inspection, send the responses to the inspector on a timely manner and by the due date.
• Continue follow up with the auditees until responses and CAPA commitments are completed and closed.

Quality Management Activities

• Risk Management and Quality Incident Management
• Apply ICH E6(R2) Risk Management principles with study teams, to identify Critical to Quality risks, Quality Tolerance Limits (QTLs) and Key Risk Indicators, thresholds
• Collaborate with study teams to monitor, manage, report study risks
• Apply ICH E6(R2) to recognize known or potential non-compliances to study protocol, GCP or other regulatory requirement
• Collaborate with study teams to identify, report, remediate Quality Incidents

Quality System Documents

• Lead process improvements through leading the creation and revision of DCRI QSDs as a QA Contact
• Apply Lean Six Sigma principles to produce effective, efficient and clear cross-functional processes
• Incorporate Quality By Design principles to meet regulatory requirements
• Lead Quality Assurance QSD creation and revision as the Lead Author
• Lead DCRI Policy creation and revision as the Lead Author

Consulting

• Consult with study team to develop Quality Agreements for high-risk, high-priority programs
• Provide consulting planned Policy and/or QSD deviation to other departments
• Provide consulting on regulatory compliance to other departments
• Educate internal and external partners on DCRI-specific and general Quality Management Systems
• Represent DCRI QA on internal and external presentations and/or initiatives
• Apply ICH and specific regulatory requirements to specific DCRI queries

Training

• Stay current with regulatory, quality, and industry trends related to GXP; mainly, GCP
• Serve as a mentor to other QA auditors, consultants and staff within Quality Management

Other Duties

Performs other related duties incidental to the work described herein.

Required Qualifications

Education/Training:

• BA/BS in a scientific discipline, prefer advanced degree

Experience:

• A minimum of 7 years' experience in pharmaceutical, medical, device, biotech, or clinical trial contract research industry, including minimum 2 years' experience in Quality Assurance and/or Regulatory Compliance/Affairs
• A Master's degree in a related field may be substituted for 2 years of required experience.

Knowledge, Skills and Abilities:

• Strong analytical, problem solving skills
• Excellent written and verbal communication and interpersonal skills
• Detail oriented, good organizational traits
• Results oriented, multi-tasking, quick learner, respond to the urgent needs of the team and show a strong track record of meeting deadlines
• Good computer skills; inclination to adopt technology to maximize efficiency
• Self-motivated, with strong leadership abilities
• Knowledge of drug development and clinical trial process
• Knowledge of 21 CFR 11, 45, 50, 56, 312, 812 45 CFR 46, 74 42 CFR 50 ICH E6 , ICH E9
• Knowledge of FDA Guidance on General Principles of Software Validation
• Knowledge of FDA Guidance on Computerized Systems Used in Clinical Investigations
• Ability to independently travel up to 50% based on business needs.

Registration, Certification or Licensure:

Not required; however, Certified Quality Auditor (CQA) and/or US Regulatory Affairs Certification (RAC US) is a plus.

Minimum Qualifications

Work generally requires a BA/BS in a scientific discipline.

A minimum of 7 years of experience in pharmaceutical, healthcare, OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE medical devices, biotech, or clinical trial contract research industry, including minimum 2 years of experience in Quality Assurance and Regulatory Compliance/ Affairs. A Master's degree in a related field may be substituted for 2 years of required experience.

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