Senior Manager QA, Remote based in North Carolina

Fortrea

Durham (NC)

Remoto

USD 93.000 - 207.000

Tempo pieno

2 giorni fa

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Vantaggi offerti da questo lavoro

Medical

Dental

Vision

Life

STD/LTD

401(K)

Paid time off (PTO) or Flexible time

Company bonus

Descrizione del lavoro

Fortrea is seeking a Senior Manager QA, External Audit, Remote based in North Carolina to lead client audits, for-cause audits, and regulatory inspections. You will shape readiness programs, guide response strategies, and drive a culture of quality across clinical operations in collaboration with cross-functional partners.

Preference will be given to candidates in the Raleigh-Durham area. The role involves travel to sites, partnering with regulatory agencies, mentoring leaders, implementing

Competenze

10+ years in GxP auditing, QA, regulatory inspection support, or external audit hosting.
Experience leading sponsor audits, regulatory inspections, or for-cause audits.
Experience providing senior-level oversight of audit findings and CAPAs.
Experience leading cross-functional teams and audit readiness strategy.
Previous line management experience across multiple sites.

Mansioni

Oversee and lead execution of client audits, for-cause audits, and inspection activities.
Provide strategic oversight for complex external audit and inspection activities.
Partner with regional and functional leaders to support quality culture.
Ensure consistent SOP use and interpretation of quality regulations.
Communicate escalations and lead preventative actions.
Lead process improvement initiatives using data, metrics, dashboards.
Manage interactions with clients and regulatory agencies.
Recruit, train, coach, and develop leaders across sites.
Perform other duties as assigned.

Conoscenze

GxP auditing

Quality assurance

Regulatory inspection support

External audit hosting

Clinical research quality

Audit coordination

Cross-functional leadership

Senior-level oversight

Line management

Formazione

Bachelor's degree in Life Sciences

Descrizione del lavoro

Senior Manager QA, Remote based in North Carolina

Join Fortrea as a Senior Manager QA, External Audit, NC remote based and make an impact on the quality of clinical research by leading critical audit and inspection programs. In this highly collaborative role, you'll influence a culture of quality, strengthen quality systems, and drive continuous improvement across clinical operations.

Location: Preference will be given to candidates located in or near the Raleigh-Durham, North Carolina area.

Key / Core Responsibilities

You will oversee and lead the execution of client audits, for-cause audits and inspection activities, ensuring appropriate staffing, planning, conduct and follow-through to meet client and regulatory inspector expectations.
You will 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.
You will partner with regional and functional leaders on key initiatives, providing Quality SME input and supporting a strong culture of quality.
You will ensure consistent functional implementation, use and review of SOPs and interpret applicable quality regulations and standards to ensure appropriate policies and procedures are revised or created.
You will communicate escalation issues to management and lead appropriate solutions, including preventative actions, risk mitigation and regular leadership updates.
You will lead functional process improvement initiatives, using data analysis, metrics and dashboards to drive the efficiency and effectiveness of Regulatory Compliance and Quality Assurance processes.
You will lead and effectively manage critical interactions with clients and regulatory agencies and represent Fortrea during external meetings, conferences and seminars as an industry SME.
You will recruit, train, coach and develop leaders and mentor RC and QA resources, including performance and workload management across multiple sites or geographic locations.
And all other duties as assigned

Required Qualifications

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.

Preferred

A bachelor's degree in Life Sciences is preferred, or equivalent Life Science experience. Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
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.

Fortrea is unable to provide employment sponsorship for this position, now or in the future. Candidates must be authorized to work in the United States without sponsorship.

Work Environment:

Work is performed in an office environment with exposure to electrical office equipment.
Occasional drives to site locations with occasional travel both domestic and international.

Physical Requirements:

Frequently stationery for 6-8 hours per day.
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
Regular and consistent attendance.
Varied hours may be required.

Pay Range:

USD $93,300-206,800 / annually

Benefits:

All job offers will be based on a candidate's skills and prior relevant experience, applicabledegrees/certifications,as well as internal equity and market data.Regular,full-timeor part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable.