Quality Record Investigation Lead Consultant

<h3>Accountabilities</h3><li>
<strong>Client relationship management:</strong>Serve as the primary client interface, maintaining clear communication, coordinating priorities, and ensuring alignment on project objectives and deliverables.</li><li>
<strong>Project management:</strong>Oversee the execution of quality record investigation and closure activities, managing timelines, milestones, resources, and overall delivery performance throughout the six-week engagement.</li><li>
<strong>KPI tracking and performance monitoring:</strong>Establish and monitor key performance indicators (KPIs), track team productivity, assess progress against targets, and implement corrective actions when needed.</li><li>
<strong>Status reporting:</strong>Prepare and deliver weekly project status reports, providing clear updates on completed activities, outstanding records, performance metrics, risks, and upcoming priorities.</li><li>
<strong>Risk and issue management:</strong>Identify potential project risks, delays, and operational challenges, escalating issues and exceptions promptly while coordinating appropriate resolutions.</li><li>
<strong>Team leadership and oversight:</strong>Supervise day-to-day team activities, monitor workloads and productivity, provide direction, and help ensure that quality standards and project deadlines are consistently met.</li><li>
<strong>Investigation and closure support:</strong>Contribute to the execution of exception and non-conformance investigations, documentation, and record closure activities when additional support is required.</li><li>
<strong>Quality and compliance oversight:</strong>Promote accurate documentation, consistent application of established procedures, and timely completion of assigned quality records within the client environment.</li><h2>Requirements</h2><li>
<strong>Relevant professional experience:</strong>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.</li><li>
<strong>Leadership and project management:</strong>Demonstrated ability to lead teams, coordinate complex workloads, manage project milestones, and deliver results within tight deadlines.</li><li>
<strong>Technical quality expertise:</strong>Strong knowledge of investigation processes, batch-related documentation, exception management, non-conformance handling, and quality record closure in a regulated environment.</li><li>
<strong>Client-facing experience:</strong>Proven ability to serve as a primary client contact, manage stakeholder expectations, communicate progress, and address concerns professionally.</li><li>
<strong>KPI and reporting capabilities:</strong>Experience tracking operational performance metrics, evaluating productivity, preparing status reports, and using data to support decisions and improve execution.</li><li>
<strong>Risk management and problem-solving:</strong>Strong analytical and critical-thinking skills, with the ability to identify issues early, assess potential impacts, escalate appropriately, and coordinate effective resolutions.</li><li>
<strong>Communication skills:</strong>Excellent written and verbal communication skills, including the ability to present project updates, document findings, and communicate priorities clearly to different stakeholders.</li><li>
<strong>Organizational skills:</strong>Strong planning, prioritization, and time-management abilities, with a proven capacity to manage competing demands while maintaining accuracy and attention to detail.</li><li>
<strong>Independent and collaborative working style:</strong>Comfortable taking ownership of project delivery while motivating team members and collaborating effectively within a client organization.</li><li>
<strong>On-site availability:</strong>Willingness and ability to work on-site at the client facility in Chicago, Illinois, for the duration of the six-week project.</li><h2>Benefits</h2><li>
<strong>Focused project engagement:</strong>A six-week assignment offering the opportunity to lead a defined quality and compliance initiative within the life sciences sector.</li><li>
<strong>Leadership responsibilities:</strong>The opportunity to oversee team performance, coordinate project execution, and act as the primary client contact.</li><li>
<strong>Professional development:</strong>Further develop expertise in quality investigations, regulated documentation, project management, and operational performance monitoring.</li><li>
<strong>Meaningful impact:</strong>Contribute to timely record closure, improved productivity, and effective quality management in a regulated environment.</li><li>
<strong>Collaborative working environment:</strong>Work closely with client stakeholders and a project team to resolve challenges and achieve shared objectives.</li><li>
<strong>Compensation:</strong>Salary or contract rate details have not been specified in the available job description.</li><li>
<strong>Additional benefits:</strong>Healthcare coverage, paid time off, bonuses, and other benefits have not been specified for this project-based opportunity.</li><li>
<strong>Work arrangement:</strong>This engagement is on-site at the client facility in Chicago, Illinois; remote or hybrid flexibility is not specified for the project.</li>