Senior Manager, QA

Posted 2hrs ago

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Job Description

Senior Manager QA at Fortrea, a clinical research organization, leading external audits, inspections, and quality improvement. Remote role based in North Carolina.

Responsibilities:

  • 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:

  • 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:

  • 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