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About the Role

As a GCP Clinical Auditor II, you will lead and perform complex internal and external audits to ensure compliance with quality assurance processes, global regulatory guidelines, and client requirements. You will identify compliance issues, assess root causes, and develop strategies to address risks. This role may also involve technical document reviews and other GCP activities.

Responsibilities

• Conduct and/or lead a variety of client, internal, and GCP audits, as well as activities supporting regulatory inspections.
• Lead directed clinical site and facility audits.
• Provide GCP consultation and quality support to project teams and external clients.
• Lead process audits and participate as a co-auditor on more complex system audits.
• Perform additional QA audits and activities, which may include database audits, clinical study report audits, sample results table reviews, and process-improvement initiatives.
• Serve as a resource point for operational teams on audit and quality assurance topics.
• Prepare, communicate, and present audit findings and other quality-related information at departmental, internal operations, and client meetings.

Requirements

• Bachelor's degree or equivalent relevant formal academic or vocational qualification.
• Previous Quality Assurance experience that provides the knowledge, skills, and abilities required to perform the role (comparable to 2-5 years’ experience).
• Audit experience in a regulated industry (clinical research or pharmaceutical highly preferred).
• Detailed knowledge of Good Clinical Practice (GCP) and applicable regional clinical research regulations and guidelines.
• Demonstrated experience successfully leading a range of project-based and/or internal GCP audits and vendor audits.
• Excellent written and verbal communication skills.
• Strong problem-solving, risk-assessment, and impact-analysis capabilities.
• Solid experience conducting root cause analysis.
• Strong negotiation and conflict-management skills.
• Ability to work effectively in a dynamic environment, manage multiple priorities, and balance competing demands and workloads.
• Ability to travel as required for the role (up to 50%).
• Valid driver's license and ability to meet applicable company requirements associated with business travel.
• An equivalent combination of appropriate education, training, and/or directly related experience may be considered in place of the stated qualifications.
• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• Must be legally authorized to work in the United States without sponsorship.
• Must be able to pass a comprehensive background check, which includes a drug screening.

Skills

• Good Clinical Practice (GCP)
• Quality Assurance
• Auditing
• Risk Assessment
• Root Cause Analysis
• Communication
• Problem-Solving
• Negotiation
• Conflict Management

Location

• Remote United States

Work Type

• Office
• Home-based
• Standard (Mon-Fri)

Experience Level

• 2-5 years’ experience
• Senior

Education Level

• Bachelor's degree or equivalent

Salary/Compensations

• $60,000 - $90,000 USD

Benefits

• Variable annual bonus based on company, team, and/or individual performance results

About the Company

• Join the PPD™ clinical research business of Thermo Fisher Scientific, a globally recognized leader in drug development and laboratory services.
• We partner with leading pharmaceutical, biotech, medical device, academic, and government organizations to bring life-changing therapies to market.
• By joining our team, you will be part of groundbreaking medical discoveries and gain invaluable experience and growth opportunities in your field.

Equal Opportunity

• At Thermo Fisher Scientific, we are committed to fostering a healthy and harmonious workplace for our employees. We understand the importance of creating an environment that allows individuals to excel.