GCP QA Auditor III

This is a fully remote position, open to applicants in Texas.

📋 Description

• Oversee intricate internal and external audits across multiple departments.

• Ensure adherence to quality assurance procedures, standards, global regulatory requirements, and client contracts.

• Detect quality and regulatory compliance challenges and analyze the root causes of non-conformance.

• Formulate strategies to resolve quality and compliance concerns.

• Conduct technical document evaluations and engage in other Good Clinical Practice (GCP) activities.

• Carry out or lead client, internal, and GCP audits as well as regulatory inspections.

• Guide audits of sites, facilities, vendors, and subcontractors.

• Offer GCP advice and assistance to project teams and external clients.

• Direct process audits and act as a co-auditor in complex system audits.

• Execute database audits, audits of clinical study reports, sample results table audits, and process enhancement activities.

• Act as a quality assurance resource for operational departments.

• Compile and present audit results at departmental, internal operations, and client meetings.

• Mentor and provide guidance to junior auditors.

• Draft comprehensive audit reports for management review.

• Strategize and deliver chargeable quality services for clients and projects.

• Serve as a point of contact for clients when necessary.

⛳️ Requirements

• Bachelor's degree or an equivalent relevant academic/vocational qualification.

• Prior GCP QA experience equivalent to 5+ years.

• Consideration may be given to a combination of suitable education, training, and/or directly relevant experience.

• In-depth knowledge of GCP and applicable regional research regulations and guidelines.

• Proven expertise in project-based or internal GCP audits and vendor audits.

• Exceptional verbal and written communication skills.

• Strong abilities in problem-solving, risk assessment, and impact analysis.

• Comprehensive experience in root cause analysis.

• Above-average negotiation and conflict resolution skills.

• Capacity to manage multiple tasks and prioritize competing workloads.

• Valid driver’s license required.

• Ability to qualify for and maintain a corporate credit card with an adequate credit limit for business travel.

🏝️ Benefits

• Global team environment.

• Opportunities for collaboration and professional development.

• Work atmosphere focused on scientific excellence.