Qa Manager Jobs

About The Position

Requirements

• At least 10 years of specialized GxP auditing, quality assurance, regulatory inspection support, external audit hosting, or related clinical research quality experience.
• 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 to leadership, and driving audit or inspection readiness strategy.
• Previous line-management experience, including performance management, coaching, and workload management, and the ability to lead and support teams across multiple sites or geographic locations.
• Must be authorized to work in the United States without sponsorship, now or in the future.
• Ability to access and use a variety of in-house and off-the-shelf computer software.
• Regular and consistent attendance.

Nice To Haves

• At least 5 years of experience leading, managing, hosting, or coordinating sponsor audits, regulatory inspections, or for-cause audits is preferred.
• A bachelor's degree in Life Sciences or equivalent Life Science experience is preferred; relevant and equivalent experience may be considered in lieu of educational requirements.
• Experience and regulatory expertise in industry quality systems and standards, including interpreting applicable regulations and using data to lead process-improvement initiatives.

Responsibilities

• Oversee and lead the execution of client audits, for-cause audits, and inspection activities, including appropriate staffing, planning, conduct, and follow-through.
• Provide strategic oversight for complex or high-risk external audit and inspection activities, including readiness planning, stakeholder engagement, response strategy, escalation management, and leadership communication.
• Partner with regional and functional leaders on initiatives, providing Quality subject-matter expertise and supporting a strong culture of quality.
• Ensure consistent functional implementation, use, and review of SOPs; interpret applicable quality regulations and standards to ensure appropriate policies and procedures are revised or created.
• Communicate escalation issues to management and lead solutions, including preventative actions, risk mitigation, and regular leadership updates.
• Lead functional process-improvement initiatives using data analysis, metrics, and dashboards to improve the efficiency and effectiveness of Regulatory Compliance and Quality Assurance processes.
• Lead critical interactions with clients and regulatory agencies and represent Fortrea at external meetings, conferences, and seminars as an industry subject-matter expert.
• Recruit, train, coach, and develop leaders; mentor Regulatory Compliance and Quality Assurance resources; and manage performance and workloads across multiple sites or geographic locations.
• Perform other duties as assigned.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Life insurance
• Short-term and long-term disability
• 401(k)
• Paid time off (PTO) or flexible time off (FTO)
• Company bonus where applicable