Senior Manager, QA

🔥 43 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $93.3k - $206.8k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 0%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• 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

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume