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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in GxP Auditing, Quality Assurance, and Regulatory Inspection, with a strong focus on leading cross-functional teams and managing complex stakeholder expectations. Proven ability to interpret quality regulations, implement process improvements, and mentor leaders across multiple sites.
Highest-signal resume keywords
GxP AuditingQuality AssuranceRegulatory Inspection SupportProcess Improvement InitiativesStakeholder Engagement
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Audit Findings OversightCorrective ActionsCAPAsData AnalysisMetrics and Dashboards
Soft Skills
Leadership CommunicationCoachingPerformance Management
Tools & Technologies
Computer Software
Industry Keywords
Quality RegulationsSOPsClinical ResearchExternal Audit HostingRisk Mitigation
About the role
Key responsibilities & impact- Oversee and lead execution of client audits, for-cause audits, and inspection activities
- Provide strategic oversight for complex or high-risk external audit and inspection activities
- Lead readiness planning, stakeholder engagement, response strategy, escalation management, and leadership communication
- Partner with regional and functional leaders on key initiatives as a Quality SME
- Ensure functional implementation, use, and review of SOPs
- Interpret applicable quality regulations and standards and ensure policies and procedures are revised or created
- Communicate escalation issues to management and lead solutions, including preventative actions and risk mitigation
- Lead functional process improvement initiatives using data analysis, metrics, and dashboards
- Lead interactions with clients and regulatory agencies
- Represent Fortrea during external meetings, conferences, and seminars as an industry SME
- Recruit, train, coach, and develop leaders
- Mentor RC and QA resources and manage performance and workload across multiple sites or geographic locations
- Perform other duties as assigned
Requirements
What you’ll need- 10+ years of specialized GxP auditing, quality assurance, regulatory inspection support, external audit hosting, or related clinical research quality experience
- At least 5 years of experience leading, managing, hosting, or coordinating sponsor audits, regulatory inspections, or for-cause audits preferred
- Demonstrated experience providing senior-level oversight of audit findings, response strategies, root cause rationale, corrective actions, CAPAs, evidence, escalation and closure activities
- Experience leading cross-functional teams, managing complex stakeholder expectations, presenting leadership, and driving audit or inspection readiness strategy
- Previous line management experience including performance management, coaching, and workload management, with the ability to lead and support teams across multiple sites or geographic locations
- A bachelor’s degree in Life Sciences is preferred, or equivalent Life Science experience
- Experience and regulatory expertise in industry quality systems and standards, including the ability to interpret applicable regulations and use data to lead process improvement initiatives
- Candidates must be authorized to work in the United States without sponsorship
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf
- Regular and consistent attendance
- Varied hours may be required
- Occasional drives to site locations with occasional domestic and international travel
Benefits
Comp & perks- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Short-term disability (STD) and long-term disability (LTD)
- 401(K)
- Paid time off (PTO) or flexible time off (FTO)
- Company bonus where applicable
- Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits