Quality Record Investigation Lead Consultant in United States at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Quality Record Investigation Lead Consultant based in the United States.

We are seeking an experienced Quality Record Investigation Lead Consultant to oversee quality investigation and record closure activities within a regulated life sciences environment. In this leadership role, you will coordinate the review, investigation, documentation, and closure of low-risk non-conformance and batch-related records within a six-week project timeline. You will serve as the primary point of contact for the client, ensuring effective communication, project coordination, and consistent delivery against established milestones. The position combines project management, team leadership, performance monitoring, and hands-on quality expertise to maintain productivity and compliance. Working on-site at a client facility in Chicago, Illinois, you will drive operational efficiency while proactively managing risks, issues, and exceptions. This opportunity is ideal for a quality professional who excels at leading teams, managing stakeholders, and delivering measurable results in a fast-paced, highly regulated environment.

• Client relationship management: Serve as the primary client interface, maintaining clear communication, coordinating priorities, and ensuring alignment on project objectives and deliverables.
• Project management: Oversee the execution of quality record investigation and closure activities, managing timelines, milestones, resources, and overall delivery performance throughout the six-week engagement.
• KPI tracking and performance monitoring: Establish and monitor key performance indicators (KPIs), track team productivity, assess progress against targets, and implement corrective actions when needed.
• Status reporting: Prepare and deliver weekly project status reports, providing clear updates on completed activities, outstanding records, performance metrics, risks, and upcoming priorities.
• Risk and issue management: Identify potential project risks, delays, and operational challenges, escalating issues and exceptions promptly while coordinating appropriate resolutions.
• Team leadership and oversight: Supervise day-to-day team activities, monitor workloads and productivity, provide direction, and help ensure that quality standards and project deadlines are consistently met.
• Investigation and closure support: Contribute to the execution of exception and non-conformance investigations, documentation, and record closure activities when additional support is required.
• Quality and compliance oversight: Promote accurate documentation, consistent application of established procedures, and timely completion of assigned quality records within the client environment.

• Relevant professional experience: Significant experience in quality assurance, quality investigations, non-conformance management, or batch record review and closure within the pharmaceutical, biotechnology, medical device, or broader life sciences industry.
• Leadership and project management: Demonstrated ability to lead teams, coordinate complex workloads, manage project milestones, and deliver results within tight deadlines.
• Technical quality expertise: Strong knowledge of investigation processes, batch-related documentation, exception management, non-conformance handling, and quality record closure in a regulated environment.
• Client-facing experience: Proven ability to serve as a primary client contact, manage stakeholder expectations, communicate progress, and address concerns professionally.
• KPI and reporting capabilities: Experience tracking operational performance metrics, evaluating productivity, preparing status reports, and using data to support decisions and improve execution.
• Risk management and problem-solving: Strong analytical and critical-thinking skills, with the ability to identify issues early, assess potential impacts, escalate appropriately, and coordinate effective resolutions.
• Communication skills: Excellent written and verbal communication skills, including the ability to present project updates, document findings, and communicate priorities clearly to different stakeholders.
• Organizational skills: Strong planning, prioritization, and time-management abilities, with a proven capacity to manage competing demands while maintaining accuracy and attention to detail.
• Independent and collaborative working style: Comfortable taking ownership of project delivery while motivating team members and collaborating effectively within a client organization.
• On-site availability: Willingness and ability to work on-site at the client facility in Chicago, Illinois, for the duration of the six-week project.

• Focused project engagement: A six-week assignment offering the opportunity to lead a defined quality and compliance initiative within the life sciences sector.
• Leadership responsibilities: The opportunity to oversee team performance, coordinate project execution, and act as the primary client contact.
• Professional development: Further develop expertise in quality investigations, regulated documentation, project management, and operational performance monitoring.
• Meaningful impact: Contribute to timely record closure, improved productivity, and effective quality management in a regulated environment.
• Collaborative working environment: Work closely with client stakeholders and a project team to resolve challenges and achieve shared objectives.
• Compensation: Salary or contract rate details have not been specified in the available job description.
• Additional benefits: Healthcare coverage, paid time off, bonuses, and other benefits have not been specified for this project-based opportunity.
• Work arrangement: This engagement is on-site at the client facility in Chicago, Illinois; remote or hybrid flexibility is not specified for the project.