Investigations Manager

Laboratoire Guerbet•Raleigh, IL

About The Position

The Investigations Manager will be operating in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for. The Investigations Manager is responsible for leading the personnel, processes, and systems that support Quality Compliance. This role oversees deviation, exception, and compliant investigations and ensures robust execution of the associated Corrective and Preventive Action (CAPA) processes. As a key member of the Quality Leadership Team, the Investigations Manager drives compliance-focused programs that enable the Quality Department to meet internal standards and external regulatory and customer requirements. The role requires strong technical expertise, sound judgment, and data-driven decision-making to support manufacturing, quality, and operational teams in a timely and effective manner.

Requirements

BA/BS in chemistry, biology, microbiology and/or life sciences.
Minimum 10 years pharmaceutical experience/laboratory management and/or related pharmaceutical experience.
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.

Nice To Haves

ASQ certification (e.g., CQA, CQE).
Six Sigma Green Belt or higher.
Prior experience in management-level investigations or quality leadership role.
Experience supporting regulatory inspections and audits.

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
Perform all duties in compliance with applicable Environmental, Health, and Safety (EHS) regulations, standards, and procedures; identify and report hazards or incidents promptly; enforce EHS requirements; and support incident investigations and corrective actions as required.
Provide backup support for other Quality systems and activities (e.g., Document Control, Change Control, Audits, Validation, Training, Labeling) to ensure continuity of operations and compliance.
Support regulatory inspections, internal audits, and vendor audits by contributing subject matter expertise, documentation review, and follow‑up actions as needed.
Participate in or support site and departmental initiatives, working groups, or task forces focused on quality improvement, compliance enhancement, or operational effectiveness.
Assist with the development, delivery, or coordination of training activities related to quality systems, investigations, CAPA, and regulatory expectations.
Contribute to the review, maintenance, and continuous improvement of quality metrics, dashboards, and reporting tools to support management review and decision‑making.
Performs other duties as assigned by management