Quality Investigations Lead - CAPA & Compliance

Guerbet; Raleigh (NC); On-site; USD 120,000 - 160,000; Full time

Job summary

Guerbet seeks an Investigations Manager to lead deviations/exception investigations, CAPA management, and remediation activities within a quality‑driven manufacturing environment in Raleigh, NC. You will oversee quality teams, ensure data integrity, and align with regulatory expectations.

You will drive site quality improvements, collaborate cross‑functionally, and mentor staff while maintaining compliance with FDA, ICH, EU, and 21 CFR Part 11 standards.

Qualifications

• BA/BS in chemistry, biology, microbiology and/or life sciences.
• Minimum 10 years pharmaceutical experience/laboratory management.
• Strong working knowledge of cGMPs, pharmaceutical manufacturing requirements, and quality systems.
• Proven experience leading deviations, investigations, CAPA, and root cause analysis in a regulated environment.
• Demonstrated ability to assess regulatory compliance risks and determine quality impact.
• Strong problem‑solving, decision‑making, and statistical analysis skills.
• Experience with electronic quality/document management systems and standard computer applications.
• Proven leadership and supervisory experience, including influencing without direct authority.
• Excellent written, verbal, interviewing, and presentation skills.
• Ability to manage multiple cross‑functional projects, operate independently, and drive change.

Responsibilities

• Provide hands-on leadership as a working manager, directly overseeing quality teams responsible for deviation/exception investigations, customer complaint investigations, CAPA management, and remediation activities.
• Serve as the site expert and authority on investigation practices, quality systems, and regulatory compliance, providing strategic direction and technical guidance to cross-functional stakeholders.
• Lead and support site quality improvement initiatives and cross-functional projects focused on compliance, operational excellence, and continuous improvement.
• Manage and develop multi-level quality teams supporting formulation, filling, and packaging operations; establish performance goals, conduct reviews, and actively mentor and develop staff.
• Maintain working knowledge of core and adjacent quality systems to provide backup support as needed, including Document Control, Change Control, Validation, Audits, Labeling, Training, and Site Inspection/Remediation Programs.
• Ensure robust data integrity oversight, including data review, investigation coordination, and assignment and completion of corrective and preventive actions.
• Proactively identify quality and compliance risks and, in partnership with the Site Quality Manager, recommend and drive effective corrective and preventive actions.
• Maintain compliance with applicable cGMP/GxP regulations and global regulatory standards, including FDA, ICH, EU, 21 CFR Part 11, and other applicable health authority requirements.
• Evaluate and improve systems, processes, metrics, and tools to enhance investigation quality, compliance performance, and operational efficiency, including the application of Lean and continuous improvement methodologies.
• Develop, review, approve, and support quality documentation, including SOPs, investigations, reports, validation protocols, change requests, risk assessments, and technical and laboratory documentation.
• Apply a strong working knowledge of quality, laboratory, manufacturing, validation, facilities, utilities, and sterile manufacturing processes (aseptic and terminal sterilization).
• Develop and deliver training and presentations to individuals and groups to ensure effective understanding and execution of quality and compliance expectations.
• Track, analyze, and report investigation, CAPA, and compliance metrics; present results and trends during Quality Management Review (QMR) meetings.
• Demonstrate sound judgment, professionalism, and the ability to make timely, data‑driven decisions in a fast‑paced manufacturing environment while supporting broader Guerbet Quality Plan and departmental goals.
• Ensure ongoing inspection readiness and support regulatory inspections, internal audits, and vendor audits.
• Performs other duties as assigned by management

Skills

Leadership

Investigations

CAPA

Regulatory compliance

Quality systems

Problem solving

Data analysis

Statistics

Documentation

Project management

Education

BA/BS in chemistry, biology, microbiology and/or life sciences

ASQ certification

Job description

Guerbet seeks an Investigations Manager to lead deviations/exception investigations, CAPA management, and remediation activities within a quality‑driven manufacturing environment in Raleigh, NC. You will oversee quality teams, ensure data integrity, and align with regulatory expectations.

You will drive site quality improvements, collaborate cross‑functionally, and mentor staff while maintaining compliance with FDA, ICH, EU, and 21 CFR Part 11 standards.