Senior Manager, QA

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Oversee and manage the execution of client audits, for-cause audits, and inspection activities.

• Provide strategic direction for complex or high-risk external audit and inspection activities.

• Lead readiness planning, engage stakeholders, formulate response strategies, manage escalations, and facilitate leadership communication.

• Collaborate with regional and functional leaders on key initiatives as a Quality Subject Matter Expert (SME).

• Ensure the functional implementation, utilization, and review of Standard Operating Procedures (SOPs).

• Interpret applicable quality regulations and standards, ensuring that policies and procedures are updated or created as necessary.

• Communicate escalation issues to management and spearhead solutions, including preventative measures and risk mitigation strategies.

• Drive functional process improvement initiatives by utilizing data analysis, metrics, and dashboards.

• Manage interactions with clients and regulatory agencies.

• Represent Fortrea at external meetings, conferences, and seminars as an industry SME.

• Recruit, train, mentor, and develop leadership personnel.

• Provide mentorship to RC and QA resources while managing performance and workload across various sites or geographic regions.

• Perform additional duties as assigned.

⛳️ Requirements

• A minimum of 10 years of specialized experience in GxP auditing, quality assurance, regulatory inspection support, external audit hosting, or related clinical research quality roles.

• At least 5 years of experience in leading, managing, hosting, or coordinating sponsor audits, regulatory inspections, or for-cause audits is preferred.

• Proven experience in providing senior-level oversight of audit findings, response strategies, root cause analysis, corrective actions, CAPAs, evidence, and closure activities.

• Experience in leading cross-functional teams, managing complex stakeholder expectations, presenting to leadership, and driving audit or inspection readiness strategies.

• Previous line management experience, including performance management, coaching, and workload oversight, 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 experience in Life Sciences.

• Expertise in industry quality systems and standards, with the ability to interpret applicable regulations and utilize data to guide process improvement initiatives.

• Candidates must be authorized to work in the United States without the need for sponsorship.

• Proficiency in accessing and utilizing a variety of computer software developed both in-house and commercially available.

• Consistent and regular attendance is required.

• Flexibility in working hours may be necessary.

• Occasional travel to site locations may occur, including domestic and international travel.

🏝️ Benefits

• Medical insurance

• Dental insurance

• Vision insurance

• Life insurance

• Short-term disability (STD) and long-term disability (LTD)

• 401(K) plan

• Paid time off (PTO) or flexible time off (FTO)

• Company bonus potential where applicable

• Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits.